EN 1041:2008+A1:2013

Superseded

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INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

Available format(s):

Superseded date: 05-14-2021

Language(s):

Published date: 12-01-2019

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
        Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling for
        instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 90/385/EC
Bibliography

Abstract - (Show below) - (Hide below)

Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.

General Product Information - (Show below) - (Hide below)

Committee	TC 3
Development Note	2008 Edition Re-Issued in September 2013 & incorporates AMD 1 2013. (10/2013)
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 20417:2021

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ONORM EN 1041 : 2013	Identical
UNI EN 1041 : 2000	Identical
UNI CEI EN 1041 : 2013	Identical
I.S. EN 1041:2008+A1:2013	Identical
CEI UNI EN 1041 : 2014	Identical
NBN EN 1041 : 2008 + A1 2013	Identical
NF EN 1041 : 2008-10	Identical
SN EN 1041 : 2007-10	Identical
NS EN 1041 : 2008 + A1 2013	Identical
NEN EN 1041 : 2008 + A1 2013	Identical
DIN EN 1041:2013-12	Identical
BS EN 1041 : 2008	Identical
PN EN 1041 : 2010 + A1 2013	Identical
BS ISO 22526-1:2020	Identical
BS EN 1041:2008+A1:2013	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

07/30165249 DC : 0	BS EN 15154-3 - EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
CAN/CSA-ISO 16571:16	SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
BS ISO 17966:2016	Assistive products for personal hygiene that support users. Requirements and test methods
I.S. EN 740:1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
I.S. EN ISO 5364:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
CSA ISO 5361 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
UNI EN 15154-4 : 2009	EMERGENCY SAFETY SHOWERS - PART 4: NON PLUMBED-IN EYEWASH UNITS
UNI EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
BS EN ISO 14155:2011	Clinical investigation of medical devices for human subjects. Good clinical practice
15/30325867 DC : 0	BS EN 868-3 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
DIN EN 14931 E : 2006	PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
I.S. EN ISO 22523:2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
12/30261215 DC : 0	BS EN 13060 - SMALL STEAM STERILIZERS
UNI EN 1865-4 : 2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR
EN ISO 7396-1:2016	Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
08/30184612 DC : DRAFT SEP 2008	BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
14/30295064 DC : 0	BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
06/30112971 DC : DRAFT JULY 2006	ISO/IEC 62366 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
17/30336573 DC : 0	BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
17/30336577 DC : 0	BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
13/30242951 DC : 0	BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
07/30166924 DC : DRAFT AUG 2007	BS EN 868-2 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
PREN 14180 : DRAFT 2012	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN 1865-4:2012-09	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR
08/30170025 DC : DRAFT AUG 2008	BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
DIN EN 15154-3:2009-07	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
02/563808 DC : DRAFT SEP 2002	BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
02/563845 DC : DRAFT SEP 2002	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS EN 14931:2006	Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing
DIN EN ISO 15223-1:2015-08 (Draft)	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
CSA Z10651-4 : 2008	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
CSA ISO 11712 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
CSA Z10651.6 : 2006 : R2015	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
CSA Z18778 : 2008 : R2018	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
I.S. EN 14931:2006	PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
CSA Z10651.6 :2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
PREN 13060 : DRAFT 2012	SMALL STEAM STERILIZERS
CSA Z10535 : 2003	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 8836:2015-02	Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
CSA C22.2 No. 60601.2.12 : 2003	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
I.S. EN 455-4:2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
AAMI ISO 5361 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
BS EN ISO 7396-1:2016 (published 2016-03)	Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
ISO 5362:2006	Anaesthetic reservoir bags
BS EN 868-5:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN 868-10:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ISO 16571:2014	Systems for evacuation of plume generated by medical devices
CSA ISO 5362 : 2014	ANAESTHETIC RESERVOIR BAGS
CSA ISO 10079-3:14 (R2019)	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)
DIN EN 868-10 E : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN 13795:2011	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
UNI EN 14683 : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI CEI EN 980 : 2009	SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
I.S. EN 1865-2:2010	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
ISO 15798:2013	Ophthalmic implants Ophthalmic viscosurgical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
DIN EN 12470-1:2009-11	Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
DIN EN 1422:2014-08	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 7376:2010-01	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN 14254 E : 2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
DIN EN 1642:2012-06	Dentistry - Medical devices for dentistry - Dental implants
DIN EN 1060-1:2010-03	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
BS EN 1782 : 1998	TRACHEAL TUBES AND CONNECTORS
BS EN ISO 11979-4 : 2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)
BS EN 13718-1:2014	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
UNE-EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
BS EN ISO 11979-9 : 2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
BS EN 13014:2000	CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
BS EN 13795-1 : 2002	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
ISO 10651-4:2002	Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
UNE-EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
BS EN ISO 22803:2005	DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
BS EN 455-3:2015	Medical gloves for single use Requirements and testing for biological evaluation
UNE-EN ISO 14408:2016	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
BS EN 868-3:2017	Packaging for terminally sterilized medical devices Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods
BS EN ISO 22523:2006	External limb prostheses and external orthoses. Requirements and test methods
BS EN ISO 14534:2015 (published 2015-02)	Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
BS EN 1060-2 : 1996	NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS
UNE-EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
BS EN 12342 : 1998	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
BS EN ISO 7376 : 2009-08	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNE-EN ISO 16672:2016	Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
BS EN 13544-3 : 2001	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
DIN EN 1733:2003-02	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 13014:2000	CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
DIN EN 1422:1997-11	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 12342:1998-09	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:2010-01	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 10651-4:2009	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
I.S. EN ISO 18777:2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN 12470-3:2000-04	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN 14931:2006-08	Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
EN ISO 11979-4:2008/A1:2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN 868-2:2017-05	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
EN 1282-2:2005+A1:2009	Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
EN ISO 5364:2016	Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
EN 12181 : 1998	OROPHARYNGEAL AIRWAYS
EN 13014:2000/AC:2002	CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
EN 13544-2:2002+A1:2009	Respiratory therapy equipment - Part 2: Tubing and connectors
EN 62366 : 2008 AMD 1 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN 1060-1:1995+A2:2009	Non-invasive sphygmomanometers - Part 1: General requirements
EN ISO 22523 : 2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
DIN EN 868-4:2017-05	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
EN 12470-2:2000+A1:2009	Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
EN 12470-3:2000+A1:2009	Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
EN 12598 : 1999	OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
EN 12470-1:2000+A1:2009	Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
EN ISO 5366-1:2009	Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
EN 13544-1:2007+A1:2009	Respiratory therapy equipment - Part 1: Nebulizing systems and their components
PREN 1422 : DRAFT 2011	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
03/306155 DC : DRAFT APR 2003	BS EN 14683 - SURGICAL MASKS - REQUIREMENTS AND TEST METHODS
10/30215051 DC : DRAFT JUNE 2010	BS EN 1865-4 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: MECHANICAL ASSISTED TRANSFER CHAIR
BS EN 15154-3:2009	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
I.S. EN 12470-5:2003	CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
BS EN 455-4:2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
12/30262894 DC : 0	BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
PD ISO/TR 27809:2007	Health informatics. Measures for ensuring patient safety of health software
I.S. EN 16844:2017	AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
11/30243761 DC : 0	BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
I.S. EN 1865-3:2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
17/30360908 DC : 0	BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
PREN 14683 : DRAFT 2017	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
PREN 13795-1 : DRAFT 2017	SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
10/30215054 DC : DRAFT JUNE 2010	BS EN 1865-3 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
UNI EN ISO 7376 : 2009-10	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN 1865-2:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
11/30252448 DC : 0	BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
03/106945 DC : DRAFT APR 2003	BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
PREN 868-7 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
ISO 20696:2018	Sterile urethral catheters for single use
03/114562 DC : DRAFT SEP 2003	BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
ISO 17593:2007	Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
DIN EN ISO 8836 E : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
04/30057165 DC : 0	BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
14/30295067 DC : 0	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
13/30278952 DC : 0	BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
DD ENV 12718:2001	MEDICAL COMPRESSION HOSIERY
09/30192338 DC : 0	BS EN 1060-1:1996/A2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
13/30281504 DC : 0	BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
11/30212235 DC : 0	BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
15/30280904 DC : 0	BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
07/30169940 DC : 0	BS EN ISO 11979-4 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
BS EN ISO 15798 : 2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
03/111582 DC : DRAFT JULY 2003	BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
02/563832 DC : DRAFT SEP 2002	BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
13/30276231 DC : 0	BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
14/30281863 DC : 0	BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BS EN 45502-2-3:2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
09/30192341 DC : 0	BS EN 1060-2:1995/A1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS
ISO/TR 27809:2007	Health informatics Measures for ensuring patient safety of health software
BS 5724-2.204(1999) : 1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
CSA ISO 27427 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
03/111581 DC : DRAFT JULY 2003	BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS
CSA Z10535 : 2003 : R2014	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
06/30106983 DC : 0	EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS OF MEDICAL DEVICES USED IN AIR AMBULANCES
CSA ISO 16628 : 2014	TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
CSA Z8836 :2011	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
ANSI/AAMI/ISO 15223-1:2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
ISO 11249:2018	Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
DIN EN 868-8:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7396-1:2016	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
DIN EN ISO 11979-10:2014-12	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
I.S. EN 16372:2014	AESTHETIC SURGERY SERVICES
I.S. EN 62366-1:2015&AC:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNE-EN ISO 14155:2012	Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
AAMI ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
AAMI ISO 14408 : 2005	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
I.S. EN 13060:2014	SMALL STEAM STERILIZERS
AAMI ISO 8836 : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 868-5:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN 868-5:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
EN 868-5:2009	Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
BS EN 13795:2011+A1:2013	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
CSA IEC 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CAN/CSA-ISO 10079-1:16	Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)
PREN 868-3 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
AAMI ISO 14155 : 2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
CSA ISO 11712:14 (R2019)	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
UNI EN ISO 14155 : 2012	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
DIN EN 868-9:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
CSA ISO 10079-2 : 2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
NF EN 455-4 : 2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
BS EN ISO 5367:2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
UNE-EN ISO 5367:2015	Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
BS EN 868-9:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
PREN 12182 : 2009-06	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 15154-3 : 2009	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
ISO 11199-2:2005	Walking aids manipulated by both arms Requirements and test methods Part 2: Rollators
UNI EN 868-9 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
DIN EN 14683 E : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS EN 868-10:2009	PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
NF EN ISO 7376 : NOV 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
ISO 8836:2014	Suction catheters for use in the respiratory tract
ISO 5367:2014	Anaesthetic and respiratory equipment Breathing sets and connectors
DIN EN 1641:2010-02	Dentistry - Medical devices for dentistry - Materials
DIN EN 12182:2012-07	Assistive products for persons with disability - General requirements and test methods
DIN EN ISO 18779 E : 2005	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
DIN EN 12470-2:2009-11	Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009)
DIN EN ISO 22803:2006-01	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
DIN EN 1782:2009-12	TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 18778 E : 2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
DIN EN 1640:2010-02	Dentistry - Medical devices for dentistry - Equipment
DIN EN ISO 11199-2:2005-07	Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
DIN EN ISO 4074:2016-05	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
DIN EN ISO 18778:2009-08	Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
DIN EN ISO 11979-9:2014-12	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 14408:2016-07	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
DIN EN ISO 16672:2015-12	Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 18777:2009-07	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN 13544-3:2010-01	Respiratory therapy equipment - Part 3: Air entrainment devices (includes Amendment A1:2009)
DIN EN ISO 11979-9 E : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN 13544-2:2010-01	Respiratory therapy equipment - Part 2: Tubing and connectors (includes Amendment A1:2009)
DIN EN ISO 11979-4 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
BS EN 1640:2009	Dentistry. Medical devices for dentistry. Equipment
BS EN ISO 10079-2:2014 (published 2014-05)	Medical suction equipment Manually powered suction equipment
BS EN 1639:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
BS EN ISO 10651-4:2002	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
BS EN 868-7:2017	Packaging for terminally sterilized medical devices Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
BS EN 12470-3 : 2000	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNE-EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
I.S. EN ISO 14534:2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
I.S. EN 868-4:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 5366-1:2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
I.S. EN 13544-3:2001	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
I.S. EN ISO 22794:2009	DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
I.S. EN 868-3:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 18778:2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
I.S. EN 868-7:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
DIN EN 12470-5:2003-09	CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
DIN EN 12470-4:2001-02	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
I.S. EN 13544-2:2002	RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
ONORM EN ISO 11199-2 : 2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
I.S. EN ISO 10079-2:2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)
I.S. EN ISO 11334-1:2007	ASSISTIVE PRODUCTS FOR WALKING MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - PART 1: ELBOW CRUTCHES
I.S. EN 12182:2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN 868-2:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
DIN EN 1820:2009-12	ANAESTHETIC RESERVOIR BAGS
I.S. EN 1642:2011	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
I.S. EN 1640:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
I.S. EN ISO 4074:2015	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
I.S. EN 868-6:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
I.S. EN 1639:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN 13718-1 : 2014	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
I.S. EN 1422:2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
I.S. EN 1641:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
I.S. EN 12470-2:2000	CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
DIN EN 14180:2003-10	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. EN ISO 14408:2016	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
I.S. EN ISO 10651-6:2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
I.S. EN 14180:2014	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 10651-2:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
I.S. EN 12470-1:2000	CLINICAL THERMOMETERS - PART 1: METALLIC LIQUID-IN-GLASS THERMOMETERS WITH MAXIMUM DEVICE
DIN EN 1789:2014-12	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
I.S. EN 1282-2:2005	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
I.S. EN ISO 18779:2005	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
I.S. EN ISO 11199-2:2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
I.S. EN ISO 16672:2015	OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
I.S. EN ISO 10079-3:2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014)
DIN EN ISO 5366-1:2009-07	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN 1642 : 2012	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
NF EN 13544-3 : 2002 + A1 2009	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
BS ISO 15198:2004	Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
DIN EN 13795:2013-10	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
ISO/TS 16628:2003	Tracheobronchial tubes Recommendations for size designation and labelling
13/30260084 DC : 0	BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
I.S. EN 285:2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS ISO 11712:2009	Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
08/30184602 DC : DRAFT SEP 2008	BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
14/30289772 DC : 0	BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
15/30317874 DC : 0	BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS ISO 25841:2017	Female condoms. Requirements and test methods
BS EN ISO 8836:2014	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
UNE-EN 1865-1:2011	Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
14/30290166 DC : 0	BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
UNI EN ISO 11979-10 : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
I.S. EN 12181:1998	OROPHARYNGEAL AIRWAYS
BS ISO 18190:2016 (published 2016-10)	Anaesthetic and respiratory equipment. General requirements for airways and related equipment
00/563810 DC : DRAFT AUG 2000	BS EN 13544-2 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
BS EN ISO 5364:2016	Anaesthetic and respiratory equipment. Oropharyngeal airways
UNI EN ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
CAN/CSA-ISO 5364:16	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
UNE-EN ISO 5364:2017	Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
UNI EN 455-4 : 2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
13/30255929 DC : 0	BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
01/564180 DC : DRAFT OCT 2001	BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
ISO 15198:2004	Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
DD ENV 12719:2001	MEDICAL THROMBOSIS PROPHYLAXIS HOSIERY
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
09/30201992 DC : 0	BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
15/30325864 DC : 0	BS EN 868-7 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
BS EN 60601-2-12:2006	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
BS ISO 16142-1:2016	Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS ISO 28620:2010	MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
08/30176106 DC : DRAFT MAR 2008	BS EN 1865-2 - SPECIFICATION FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS
I.S. EN 16844:2017+A2:2019	Aesthetic medicine services - Non-surgical medical treatments
09/30176675 DC : 0	BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
08/30184615 DC : DRAFT SEP 2008	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
UNE-EN 16372:2015	Aesthetic surgery services
ISO 16142-1:2016	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
03/317861 DC : DRAFT OCT 2003	EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
AAMI IEC 62366 : 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
PREN 868-8 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
DD ISO/TS 16628:2003	TRACHEOBRONCHIAL TUBES - RECOMMENDATIONS FOR SIZE DESIGNATION AND LABELLING
CSA Z18779 : 2008 : R2013	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
CSA IEC 62366 : 2014	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA Z8836 : 2011 : FR	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 8836 : 2015	A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
03/103294 DC : DRAFT JAN 2003	BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
UNE-EN ISO 8836:2015	Suction catheters for use in the respiratory tract (ISO 8836:2014)
08/30178723 DC : DRAFT AUG 2008	BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
03/101659 DC : DRAFT JAN 2003	ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA Z10651-4 : 2008 : R2013	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
CSA Z10651.6 : 2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
CSA Z18778 :2008	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
UNI EN 868-10 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
DIN EN 14683:2014-07	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI EN 13795 : 2013	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
CSA Z8836 : 2011 : R2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN ISO 5361:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
CEI UNI EN 15986 : 2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
CEI EN 60601-2-12 : 2007	MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
EN ISO 16671:2015/A1:2017	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
I.S. EN 15986:2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
EN 13060:2014	Small steam sterilizers
I.S. EN 62366-1:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS EN ISO 15223-1:2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016)
BS EN 62366 : 2008	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNI EN ISO 5361 : 2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 7396-1:2016-09	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
CSA ISO 10079-3 : 2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
CEN/TR 15640:2007	Health informatics - Measures for ensuring the patient safety of health software
AAMI ISO 5362 : 2006	ANAESTHETIC RESERVOIR BAGS
I.S. EN 868-8:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
PREN 868-2 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
UNI EN ISO 5364 : 2011	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BIS IS/ISO 11979-4 : 2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELING INFORMATION
EN 16844:2017	Aesthetic medicine services - Non-surgical medical treatments
ISO 17218:2014	Sterile acupuncture needles for single use
ISO 25841:2017	Female condoms — Requirements and test methods
UNI EN 868-8 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 16671:2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
I.S. EN ISO 8836:2014	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
DIN EN ISO 18777 E : 2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN ISO 22523:2007-04	External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
DIN EN 12470-3:2009-11	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN ISO 22794:2009-11	Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
DIN EN 12470-4:2009-11	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
DIN EN ISO 11199-3:2005-07	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
DIN EN ISO 10651-6:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 10651-4:2009-08	Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
DIN EN 13060:2015-03	SMALL STEAM STERILIZERS
DIN EN 1639:2010-02	Dentistry - Medical devices for dentistry - Instruments
DIN EN 13544-1:2009-12	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
DIN EN 455-3:2015-07	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
DIN EN 13718-1:2014-12	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
DIN EN ISO 10079-3:2014-09	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
DIN EN 455-2:2015-07	MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES
DIN EN 285:2016-05	Sterilization - Steam sterilizers - Large sterilizers
DIN EN ISO 11334-1:2007-04	Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
ISO 18779:2005	Medical devices for conserving oxygen and oxygen mixtures Particular requirements
BS EN ISO 11334-1:2007 (published 2007-03)	Assistive products for walking manipulated by one arm. Requirements and test methods Elbow crutches
ISO 5364:2016	Anaesthetic and respiratory equipment — Oropharyngeal airways
BS EN 12470-5:2003	CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
ISO 5366-1:2000	Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
ISO 22794:2007	Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
EN 868-10:2009	Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
I.S. EN 1789:2007	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 868-8:2009	Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
EN ISO 7376:2009	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
EN 1789:2007+A2:2014	Medical vehicles and their equipment - Road ambulances
I.S. EN ISO 7376:2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
EN ISO 11979-9:2006/A1:2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
I.S. EN 868-10:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
UNE-EN 1282-2:2006	Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
I.S. EN ISO 11979-4:2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)
I.S. EN 13544-1:2007	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN ISO 8836:2014	Suction catheters for use in the respiratory tract (ISO 8836:2014)
EN ISO 14155:2011/AC:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
I.S. EN 1820:2005	ANAESTHETIC RESERVOIR BAGS
UNE-EN 1782:1998	TRACHEAL TUBES AND CONNECTORS.
EN 868-9:2009	Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN 62366-1:2015/AC:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 13795-1:2002+A1:2009	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
EN 1782:1998+A1:2009	Tracheal tubes and connectors
UNI EN 12470-3 : 2009	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNI EN 12470-4 : 2009	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
UNI EN 1060-2 : 2010	NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS
UNI EN 13544-3 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
UNI EN 1060-1 : 2010	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
UNI EN 1641 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
UNI EN 1640 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN 1639 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN ISO 10651-2 : 2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
UNI EN ISO 7396-2 : 2007	MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
UNI EN 12470-1 : 2009	CLINICAL THERMOMETERS - PART 1: METALLIC LIQUID-IN-GLASS THERMOMETERS WITH MAXIMUM DEVICE
UNI EN ISO 11979-4 : 2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
UNI EN ISO 11979-9 : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
UNI EN 12470-2 : 2009	CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
UNI EN ISO 5366-1 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN ISO 10079-3 : 2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
UNI EN 1282-2 : 2009	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNI EN ISO 18777 : 2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
UNI EN ISO 10079-2 : 2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
UNI EN 13544-1 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI EN 12342 : 2009	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI CEI EN 45502-2-3 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
UNI EN 13544-2 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
UNI EN ISO 10651-6 : 2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
UNI EN ISO 10651-4 : 2009	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
UNI EN ISO 18778 : 2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
UNI EN 14180 : 2014	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN 12182 : 2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 1422 : 2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
UNI EN 1820 : 2009	ANAESTHETIC RESERVOIR BAGS
UNI EN 13795-1 : 2009	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
UNI EN 1782 : 2009	TRACHEAL TUBES AND CONNECTORS
UNE-EN ISO 5361:2017	Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
BS ISO 16571:2014	Systems for evacuation of plume generated by medical devices
15/30325855 DC : 0	BS EN 868-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
15/30282343 DC : 0	BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
15/30325469 DC : 0	BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
PREN 17180 : DRAFT 2017	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
14/30244508 DC : 0	BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
07/30147554 DC : DRAFT SEP 2007	BS ISO 16628 - TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
BS EN ISO 11979-10 : 2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
09/30190221 DC : 0	BS EN 13795 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
I.S. EN ISO 7396-2:2007	MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
DIN EN 1865-1:2015-08	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
I.S. EN 1733:2002	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
07/30147572 DC : DRAFT SEP 2007	BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
02/560790 DC : DRAFT FEB 2002	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
02/563809 DC : DRAFT SEP 2002	BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
PREN 455-3 : DRAFT 2013	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
PD CEN/TR 15640:2007	HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
ISO 20697:2018	Sterile drainage catheters and accessory devices for single use
13/30259011 DC : 0	BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
ISO 18746:2016	Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
14/30281859 DC : 0	BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
UNE-EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
02/564996 DC : DRAFT NOV 2002	BS EN ISO 16201 - TECHNICAL AIDS FOR DISABLED PERSONS - REMOTE CONTROL SYSTEMS
14/30302761 DC : 0	BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
MEDDEV 2.5-7 : REV 1 : 1998	GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES
BS ISO 14408:1998	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
14/30257546 DC : 0	BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
09/30205582 DC : 0	BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
BS EN ISO 5361:2016	Anaesthetic and respiratory equipment. Tracheal tubes and connectors
18/30349834 DC : 0	BS ISO 21802 - ASSISTIVE PRODUCTS - GUIDELINES ON COGNITIVE ACCESSIBILITY - DAILY TIME MANAGEMENT
12/30244415 DC : DRAFT APR 2012	BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
PREN 868-6 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
BS EN 1865-4:2012 (published 2012-06)	Patient handling equipment used in road ambulances Foldable patient transfer chair
DIN EN 1865-3:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
03/103293 DC : DRAFT JAN 2003	BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
UNE-EN 1865-4:2012	Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
CSA Z18778 : 2008 : R2013	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
CAN/CSA-Z18777-08 (R2018)	Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations)
CSA Z7376 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
02/563818 DC : DRAFT SEP 2002	BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
BS ISO 16628:2008	Tracheobronchial tubes. Sizing and marking
CSA Z10651.2: 2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
CSA Z18777 : 2008	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
CAN/CSA-Z10651-4-08 (R2018)	Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations)
BS EN 14683:2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI CEI EN 15986 : 2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
AAMI ISO 10651-4 : 1999	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
I.S. EN ISO 15798:2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
I.S. EN 1865-1:2010	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
DIN EN ISO 5367:2015-02	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
PREN 868-4 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
ISO 16671:2015	Ophthalmic implants — Irrigating solutions for ophthalmic surgery
ISO 17966:2016	Assistive products for personal hygiene that support users Requirements and test methods
17/30359567 DC : 0	BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 15223-1:2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
UNE-EN 13060:2015	Small steam sterilizers
UNE-EN ISO 7396-1:2016	Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
EN 14683:2014	Medical face masks - Requirements and test methods
BS EN ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
ISO 14708-7:2013	Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
ISO 7396-1:2016	Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
I.S. EN 14683:2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
I.S. EN 14254:2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
I.S. EN 60601-2-12:2006	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
DIN EN 14180:2014-09	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN 868-6:2015-08 (Draft)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
DIN EN ISO 10079-1:2016-05	MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 10079-2:2014-09	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
BS EN 12181:1998	OROPHARYNGEAL AIRWAYS
ISO 18778:2005	Respiratory equipment — Infant monitors — Particular requirements
BS EN 868-2:2017	Packaging for terminally sterilized medical devices Sterilization wrap. Requirements and test methods
ISO 10651-2:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
UNE-EN ISO 10079-3:2014	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
BS EN ISO 11199-3:2005 (published 2005-04)	Walking aids manipulated by both arms. Requirements and test methods Walking tables
BS EN 1820:2005	Anaesthetic reservoir bags
ISO 7376:2009	Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
BS EN 1615:2000	ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
BS EN ISO 10651-6:2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 11979-4:2013-01	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
ISO 11979-9:2006	Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
BS EN 13544-1 : 2007	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
BS EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNE-EN 13795:2011	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
BS EN ISO 10079-3:2014	Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source
BS EN ISO 18778:2009	Respiratory equipment. Infant monitors. Particular requirements
UNE-EN ISO 4074:2016	Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
UNE-EN ISO 15223-1:2017	Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
BS EN 455-2:2015	Medical gloves for single use Requirements and testing for physical properties
BS EN 14254:2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
UNE-EN 13544-3:2001	Respiratory therapy equipment - Part 3: Air entrainment devices.
UNE-EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 13718-1:2014	Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
BS EN 1789 : 2007	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
ISO 14408:2016	Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
BS EN 12470-4 : 2001	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
ISO 16672:2015	Ophthalmic implants Ocular endotamponades
I.S. EN 13718-1:2014	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
BS EN 13060 : 2014	SMALL STEAM STERILIZERS
UNE-EN 1642:2012	Dentistry - Medical devices for dentistry - Dental implants
UNE-EN 1789:2007	Medical vehicles and their equipment - Road ambulances
ISO 14534:2011	Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
UNE-EN ISO 14534:2015	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
ISO 18777:2005	Transportable liquid oxygen systems for medical use — Particular requirements
BS EN ISO 10651-2:2004	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
BS EN 285:2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
ISO 10651-6:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
BS EN ISO 14408:2016	Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
ISO 5361:2016	Anaesthetic and respiratory equipment — Tracheal tubes and connectors
I.S. EN 455-3:2015	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
I.S. EN 455-2:2015	MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES
BS EN 1865:2000	SPECIFICATIONS FOR STRETCHERS AND OTHER PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES
BS EN 12470-2 : 2001	CLINICAL THERMOMETERS - PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
BS EN 740:1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN ISO 11199-2:2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
ISO 22523:2006	External limb prostheses and external orthoses Requirements and test methods
ISO 11979-4:2008	Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
UNE-EN 1820:2006	Anaesthetic reservoir bags (ISO 5362:2000, modified)
ISO 11334-1:2007	Assistive products for walking manipulated by one arm Requirements and test methods Part 1: Elbow crutches
BS EN 14180:2014	Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
UNE-EN 45502-2-3:2010	Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
UNE-EN 455-2:2015	Medical gloves for single use - Part 2: Requirements and testing for physical properties
BS EN 1282-2 : 2005	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
BS EN 868-4:2017	Packaging for terminally sterilized medical devices Paper bags. Requirements and test methods
UNE-EN ISO 10079-2:2014	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
I.S. EN ISO 11979-9:2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
ISO 10079-3:2014	Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
BS EN ISO 5366-1:2004	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
ISO 4074:2015	Natural rubber latex male condoms Requirements and test methods
BS EN ISO 22794:2009	DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
BS EN 868-6:2017	Packaging for terminally sterilized medical devices Paper for low temperature sterilization processes. Requirements and test methods
ISO 11199-3:2005	Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables
BS EN 1060-1 : 1996	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
BS EN 12182:2012 (published 2012-06)	Assistive products for persons with disability. General requirements and test methods
BS EN 12523:1999	External limb prostheses and external orthoses. Requirements and test methods
I.S. EN 13795-1:2002	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
BS EN 1641:2004	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
DIN EN 13795-1 E : 2009	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
EN 15154-3:2009	Emergency safety showers - Part 3: Non plumbed-in body showers
EN 15154-4:2009	Emergency safety showers - Part 4: Non plumbed-in eyewash units
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 16372:2014	Aesthetic surgery services
EN ISO 11199-3 : 2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
EN ISO 10651-4:2009	Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
EN 1060-2:1995+A1:2009	Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
EN 1865-2:2010+A1:2015 (edition 2)	Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
EN ISO 5361:2016	Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
EN 1733 : 2002	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN ISO 10651-2:2009	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
EN 1820:2005+A1:2009	Anaesthetic reservoir bags (ISO 5362:2000, modified)
EN ISO 22803:2005	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
EN 13795:2011+A1:2013	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
EN 12342:1998+A1:2009	Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN ISO 10651-6:2009	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
EN ISO 10079-2:2014	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
EN 1641:2009	Dentistry - Medical devices for dentistry - Materials
EN ISO 18779:2005	Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
EN 45502-2-3:2010	Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN 1865 : 1999	SPECIFICATIONS FOR STRETCHERS AND OTHER PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES
EN 1642:2011	Dentistry - Medical devices for dentistry - Dental implants
EN 1639:2009	Dentistry - Medical devices for dentistry - Instruments
EN 455-2:2015	Medical gloves for single use - Part 2: Requirements and testing for physical properties
EN 1865-4:2012 (edition 2)	Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
EN ISO 18777:2009	Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
EN 740:1998/A1:2004	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
EN ISO 10079-3:2014	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
EN 14931:2006	Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1640:2009	Dentistry - Medical devices for dentistry - Equipment
EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 1865-3:2012+A1:2015 (edition 2)	Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
EN ISO 22794:2009	Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
EN ISO 14408:2016	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)