ISO 15223-1:2016

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Add to Watchlist

View superseded by

This Standard has been added successfully to your Watchlist.
Please visit My Watchlist to see all standards that you are watching.

Please log in or create an account to add this standard to your Watchlist.

We could not add this standard to your Watchlist.
Please retry or contact support for assistance.

You need to be logged in to add this standard to your Watchlist.
Please log in now or create an account to add.

You already added this Product in the Watchlist.

Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

Available format(s): Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

Withdrawn date: 06-07-2021

Language(s): French, English

Published date: 02-11-2016

Publisher: International Organization for Standardization

Add to Watchlist

Abstract - (Show below) - (Hide below)

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.

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

Committee	ISO/TC 210
Development Note	Together with ISO 15223-2 supersedes ISO 15223. (01/2010) Supersedes ISO/DIS 15223-1. (11/2016)
Document Type	Standard
ISBN
Pages
Product Note	THIS STANDARD HAVE CORRECT VERSION FOR EN AND FR FOR 2017
Published
Publisher	International Organization for Standardization
Status	Withdrawn
Superseded By	ISO 15223-1:2021
Supersedes	ISO 15223-1:2012 ISO 15223:2000

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DS EN ISO 15223-1 : 2016	Identical
NF EN ISO 15223-1 : 2017	Identical
NEN EN ISO 15223-1 : 2016 + COR 2017	Identical
NS EN ISO 15223-1 : 2016	Identical
I.S. EN ISO 15223-1:2016	Identical
PN EN ISO 15223-1 : 2017	Identical
SN EN ISO 15223-1 : 2017	Identical
UNI CEI EN ISO 15223-1 : 2012	Identical
CEI UNI EN ISO 15223-1 : 2018	Identical
SS-EN ISO 15223-1:2016	Identical
NEN-EN-ISO 15223-1:2016	Identical
UNI CEI EN ISO 15223-1:2017	Identical
EN ISO 15223-1 : 2016	Identical
JIS T 3211-11:2019	Identical
IS/ISO 15223 : Part 1 : 2016	Identical
AAMI ISO 15223-1 : 2016	Identical
BS EN ISO 15223-1:2016	Identical
CEI UNI EN ISO 15223-1 : 2013	Identical
I.S. EN ISO 15223-1:2016&LC:2016	Identical
SANS 15223-1 : 1ED 2010	Identical
NEN ISO 15223-1 : 2007 AMD 1 2008	Identical
NBR ISO 15223-1 : 2015	Identical
DS ISO 15223-1 : 2007	Identical
UNE-EN ISO 15223-1:2017	Identical
KS P ISO 15223-1: translated 2019	Identical
NBN EN ISO 15223-1 : 2012	Identical
GOST R ISO 15223-1 : 2014	Identical

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

ISO 20697:2018	Sterile drainage catheters and accessory devices for single use
CSA C22.2 No. 80601-2-56 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
DIN EN ISO 13504:2012-10	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
BS EN ISO 3630-5:2011	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
DIN EN ISO 16061:2015-09	Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
CSA C22.2 No. 60601-1-11 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
BS EN 1865-3 : 2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
NF EN ISO 80601-2-61 : 2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
DIN EN ISO 3665 E : 2013	PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011)
BS EN 60601-1-11:2015 (published 2015-06)	Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
BS EN ISO 18113-2:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
DIN EN ISO 18113-4:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
EN ISO 10555-1:2013/A1:2017	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
12/30210881 DC : DRAFT APR 2012	BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
DIN EN ISO 81060-1:2012-08	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
ISO 14708-1:2014	Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
DIN EN ISO 20072:2013-10	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
CSA Z23747:2008	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
DIN EN ISO 3665:2013-07	PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011)
I.S. EN ISO 13958:2015	CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
I.S. EN ISO 80601-2-56:2017	MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
CEI EN 60601-1-11 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
DIN EN ISO 18397:2016-09	DENTISTRY - POWERED SCALER (ISO 18397:2016)
17/30338756 DC : 0	BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
15/30282343 DC : 0	BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
ISO 18190:2016	Anaesthetic and respiratory equipment General requirements for airways and related equipment
BS EN 60601-2-34 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
DIN EN ISO 3826-4:2015-12	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
BS EN ISO 80601-2-13:2012 (published 2013-02)	Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation
UNI EN ISO 3630-4 : 2009	DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS
DIN EN ISO 3826-4 E : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
DIN EN ISO 8637:2014-03	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
UNI EN ISO 81060-1 : 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
UNI EN ISO 26782 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
ISO 13960:2010	Cardiovascular implants and extracorporeal systems Plasmafilters
CSA Z23747 : 2008 : R2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
BS EN ISO 10650:2015	DENTISTRY - POWERED POLYMERIZATION ACTIVATORS
BS ISO 17966 : 2016	ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
17/30338753 DC : 0	BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT
CSA ISO 27427 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
NBR ISO 80601-2-12 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
16/30339831 DC : 0	PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE
BS EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
BS ISO 17218 : 2014	STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
I.S. EN ISO 81060-1:2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
BS EN ISO 25539-1:2017 (published 2018-05)	Cardiovascular implants. Endovascular devices Endovascular prostheses
08/30184486 DC : DRAFT JUNE 2008	BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
PREN 17180 : DRAFT 2017	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. EN ISO 13079:2011	LABORATORY GLASS AND PLASTICS WARE - TUBES FOR THE MEASUREMENT OF THE ERYTHROCYTE SEDIMENTATION RATE BY THE WESTERGREN METHOD
BS ISO 11040-7 : 2015	PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
18/30372409 DC : DRAFT APR 2018	BS EN ISO 3630-1 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 1: GENERAL REQUIREMENTS
BS ISO 16142-2 : 2017	MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
09/30186527 DC : 0	BS EN ISO 23908-1 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING
13/30260084 DC : 0	BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
15/30281262 DC : 0	BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
10/30216098 DC : 0	BS ISO 3665 - PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS
UNI EN ISO 21531 : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
UNI EN ISO 3665 : 2013	PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS
AAMI IEC 60601-2-4 : 2010/A1:2018	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
I.S. EN 285:2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
DIN EN ISO 5367 E : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
16/30348158 DC : 0	BS EN ISO 6710 - SINGLE-USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION
09/30197590 DC : 0	BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
16/30337378 DC : 0	BS EN ISO 28319 - DENTISTRY - LASER WELDING
13/30285624 DC : 0	BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
11/30255602 DC : 0	BS ISO 8536-12:2007/AMD 1 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
16/30312315 DC : 0	BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
11/30215841 DC : 0	BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS
NBR ISO 11138-1 : 2016	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
17/30359001 DC : 0	BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
BS EN ISO 80601-2-72:2015	Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
07/30157348 DC : 0	BS ISO 26782 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE ASSESSMENT OF PULMONARY FUNCTION IN HUMANS
13/30283691 DC : 0	BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED
AAMI ISO 81060-1 : 2007	NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
I.S. EN ISO 21563:2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
UNE-EN ISO 16061:2015	Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
I.S. EN ISO 5364:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
NF ISO 28620 : 2010	MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
PD IEC/TR 60878:2015	Graphical symbols for electrical equipment in medical practice
10/30212297 DC : 0	BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES
CSA ISO 5361 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
11/30227250 DC : 0	BS EN ISO 21563 - DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
BS EN ISO 14155:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
ISO 8536-12:2007	Infusion equipment for medical use Part 12: Check valves
11/30193833 DC : 0	BS EN ISO 3630-2 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 2: ENLARGERS
15/30328959 DC : 0	BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
DIN EN ISO 13958 E : 2016	CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
I.S. EN 980:2008	SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
PREN 45502-1 : DRAFT 2013	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
13/30290370 DC : 0	BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
BS EN ISO 9687 : 2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT
I.S. EN ISO 5367:2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
14/30251609 DC : 0	BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
DIN EN 1865-1:2015-08	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
BS ISO 18835:2015	INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER ANAESTHETIC SYSTEMS
DIN EN 1865-2:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
EN ISO 10650 : 2015	DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
BS ISO 15223-2 : 2010	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
EN ISO 16671:2015/A1:2017	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
15/30300279 DC : 0	BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
15/30317874 DC : 0	BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
DD ISO/TS 12417 : 2011	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
ISO 8637-1:2017	Extracorporeal systems for blood purification Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS EN ISO 8836:2014	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
08/30154605 DC : DRAFT APR 2008	BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
17/30357887 DC : 0	BS ISO 20493 - TRADITIONAL CHINESE MEDICINE - INFRARED MOXIBUSTION-LIKE INSTRUMENT
14/30289772 DC : 0	BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
13/30276989 DC : 0	BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
BS EN 16372 : 2014	AESTHETIC SURGERY SERVICES
I.S. EN ISO 14155:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
16/30331656 DC : 0	BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS
BS EN ISO 1135-3:2017 (published 2017-02)	Transfusion equipment for medical use Blood-taking sets for single use
10/30233840 DC : 0	BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
UNI EN ISO 10524-4 : 2008	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
I.S. EN 556-2:2015	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
DIN EN ISO 18113-5:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
13/30264413 DC : 0	BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
BS EN ISO 13504 : 2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
BS EN ISO 18397 : 2016	DENTISTRY - POWERED SCALER
UNI EN ISO 18113-2 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
BS EN ISO 13958 : 2015	CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN ISO 80601-2-72 E : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
17/30321202 DC : DRAFT MAY 2017	BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
13/30254718 DC : 0	BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
UNE-EN 1865-1:2011	Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
DIN EN ISO 18397 E : 2016	DENTISTRY - POWERED SCALER (ISO 18397:2016)
DIN EN ISO 8637 E : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
UNE-EN ISO 13504:2013	Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
I.S. EN ISO 6710:2017	SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
CSA C22.2 No. 60601.1 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
I.S. EN 1865-3:2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
CSA C22.2 No. 60601.2.4 : 2012 : R2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
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
CEI EN 60601-2-49 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
11/30242579 DC : 0	BS EN ISO 6873:2000 - DENTAL GYPSUM PRODUCTS
UNI EN ISO 23908 : 2013	SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING
AAMI CI86 : 2017	COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING
BS EN ISO 80601-2-56:2017	Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
PREN ISO 80601-2-61 : DRAFT 2009	MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
16/30331650 DC : 0	BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN ISO 1135-5:2015	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
BS ISO 27427 : 2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
DIN EN ISO 12417-1:2016-02	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
BIP 0113 : 2012	GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155
14/30273278 DC : 0	BS EN ISO 18397 - DENTISTRY - POWERED SCALER
DIN EN ISO 18113-1:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
BS ISO 27185 : 2012	CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
13/30267665 DC : 0	BS EN ISO 24234 - DENTISTRY - DENTAL AMALGAM
I.S. EN ISO 13504:2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
BS EN ISO 10524-4:2008 (published 2009-02)	Pressure regulators for use with medical gases Low-pressure regulators
BS EN 15986:2011 (published 2011-03)	Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
CSA C22.2 No. 60601.2.4 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
PREN 455-3 : DRAFT 2013	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
15/30289037 DC : 0	BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
DIN EN ISO 21531 E : 2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
12/30245174 DC : 0	BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
14/30295064 DC : 0	BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
14/30296389 DC : 0	BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
BS ISO 18190:2016 (published 2016-10)	Anaesthetic and respiratory equipment. General requirements for airways and related equipment
ISO 19611:2017	Traditional Chinese medicine Air extraction cupping device
BS EN ISO 81060-1 : 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
DIN EN ISO 26782:2010-02	Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)
BS EN ISO 5364:2016	Anaesthetic and respiratory equipment. Oropharyngeal airways
BS EN ISO 3630-4:2009 (published 2009-07)	Dentistry. Root canal instruments Auxiliary instruments
BS EN ISO 12417-1:2015	Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
13/30284773 DC : 0	BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
13/30257549 DC : 0	BS EN ISO 11499 - DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
NF EN ISO 80601-2-56 : 2017	MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
I.S. EN ISO 3630-5:2011	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
CAN/CSA-ISO 5364:16	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BS EN ISO 12836:2015	DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY
14/30284310 DC : 0	BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS
AAMI ISO 15675 : 2016	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
17/30358658 DC : 0	BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
16/30329598 DC : 0	BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS
AAMI ISO 5361 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 1135-5:2016-06	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
DIN EN ISO 80601-2-72:2016-04	Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
UNE-EN ISO 11978:2018	Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
ISO 20696:2018	Sterile urethral catheters for single use
BS EN ISO 21563:2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
DIN EN ISO 13017:2016-05	DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
BS EN ISO 80601-2-69:2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
14/30295067 DC : 0	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
PD ISO/TS 17518:2015 (published 2015-05)	Medical laboratories. Reagents for staining biological material. Guidance for users
I.S. EN ISO 18397:2016	DENTISTRY - POWERED SCALER (ISO 18397:2016)
10/30195943 DC : 0	BS ISO 12891-1 - IMPLANTS FOR SURGERY - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 1: RETRIEVAL AND HANDLING
BS EN ISO 18113-1:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
BS ISO 20749 : 2017	DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
DIN EN ISO 1135-3 : 2014	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
13/30259011 DC : 0	BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
UNE-EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
14/30281859 DC : 0	BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 1135-3 E : 2017	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
AAMI ISO 8637 : 2010	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
16/30310674 DC : 0	BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS
UNI EN ISO 80601-2-69 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
UNE-EN ISO 5364:2017	Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
13/30245306 DC : 0	BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS
13/30263416 DC : 0	BS EN ISO 9687 - DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT
UNE-EN ISO 16671:2016	Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
BS EN ISO 3826-2:2008	Plastics collapsible containers for human blood and blood components Graphical symbols for use on labels and instruction leaflets
10/30168898 DC : 0	BS EN ISO 24234/A1 - REQUIREMENTS FOR MARKING AND MANUFACTURER'S INSTRUCTIONS CONCERNING MERCURY
14/30263397 DC : 0	BS EN ISO 22674 - DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES
13/30240399 DC : 0	ISO/IEC GUIDE 51 - SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS
BS EN ISO 3665 : 2013	PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS
15/30321502 DC : 0	BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
BS ISO 12891-1:2015	RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 1: RETRIEVAL AND HANDLING
DIN EN ISO 8836 E : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
13/30268585 DC : 0	BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT
UNI EN ISO 18113-5 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING
09/30203808 DC : 0	BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
BS EN ISO 18113-3:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
16/30346073 DC : 0	BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
DIN EN ISO 21531:2009-08	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
14/30281856 DC : 0	BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
CAN/CSA-C22.2 NO. 80601-2-70:17	Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations)
BS EN ISO 3826-4 : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES
PD ISO/IEC GUIDE 51:2014 (published 2014-04)	Safety aspects. Guidelines for their inclusion in standards
UNE-EN ISO 3630-4:2010	Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009)
13/30233325 DC : 0	BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
UNI EN ISO 13504 : 2012	DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
CEI EN 60601-2-4 : 2012	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
UNE-EN ISO 10079-1:2016	Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
13/30284770 DC : 0	BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
BS ISO 8536-12 : 2007	INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
BS ISO 3665 : 2011	PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS
AAMI ISO 25539-1 : 2017	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
NF ISO 15223-2 : 2010	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
BS 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
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
NBR ISO 80601-2-55 : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
13/30284776 DC : 0	BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
14/30303657 DC : 0	BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
13/30278952 DC : 0	BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
UNE-EN ISO 18113-4:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
DIN EN 14683:2014-07	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
14/30292011 DC : 0	BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
UNE-EN ISO 13079:2011	Laboratory glass and plastics ware. Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
17/30336573 DC : 0	BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
DIN EN ISO 13079:2011-10	Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
DIN EN ISO 8638:2014-03	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
DIN EN ISO 18113-3:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
PREN ISO 11499 : DRAFT 2013	DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO/DIS 11499:2013)
ISO 11040-6:2012	Prefilled syringes Part 6: Plastic barrels for injectables
13/30268148 DC : 0	BS EN ISO 11978 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING
16/30310949 DC : 0	BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
CSA C22.2 No. 61010.2.101 : 2015	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
DIN EN ISO 9687:2015-05	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
I.S. EN ISO 18113-1:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
BS EN ISO 5361:2016 (published 2016-10)	Anaesthetic and respiratory equipment. Tracheal tubes and connectors
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
NBR ISO 5367 : 2017	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
DIN EN ISO 1135-5 E : 2016	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
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
11/30193150 DC : 0	BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN ISO 11978:2017	Ophthalmic optics. Contact lenses and contact lens care products. Labelling
BS EN ISO 13079 : 2011	LABORATORY GLASS AND PLASTICS WARE - TUBES FOR THE MEASUREMENT OF THE ERYTHROCYTE SEDIMENTATION RATE BY THE WESTERGREN METHOD
09/30181956 DC : DRAFT MAY 2009	BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
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
UNI EN ISO 80601-2-12 : 2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
15/30280904 DC : 0	BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
DIN EN ISO 80601-2-69 E : 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014)
BS EN ISO 15798 : 2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
DIN EN ISO 13958:2016-03	CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
BS EN ISO 26782 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
BS EN 60601-1-12:2015 (published 2015-06)	Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
14/30263409 DC : 0	BS EN ISO 3630-3 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 3: COMPACTORS: PLUGGERS AND SPREADERS
BS EN ISO 18113-4:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
AAMI ISO 11138-1 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
BS ISO 18666 : 2015	TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
BS EN ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
13/30284721 DC : 0	BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS
DIN ISO 8536-12:2013-04	Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
ISO 16628:2008	Tracheobronchial tubes Sizing and marking
AAMI IEC 60601-2-4 : 2010 : R2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
CSA ISO 8638 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS ISO 22413 : 2010	TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - 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
13/30272807 DC : 0	BS ISO 18835 - INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT
BS EN ISO 18113-5:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
PREN ISO 80601-2-55 : DRAFT 2009	MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
14/30287632 DC : 0	BS EN ISO 12836:2012/AMD 1 - DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY
DIN EN 1865-3:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
AAMI ISO 81060-1 : 2007 : R2013	NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
UNE-EN 16372:2015	Aesthetic surgery services
10/30195946 DC : DRAFT DEC 2010	BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
DIN EN ISO 12836:2015-11	DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY (ISO 12836:2015)
14/30294895 DC : 0	BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
14/30281863 DC : 0	BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
13/30270468 DC : 0	BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
I.S. EN 16844:2017	AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS EN ISO 8638 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
PREN ISO 24234 : DRAFT 2013	DENTISTRY - DENTAL AMALGAM (ISO/DIS 24234:2013)
15/30312454 DC : 0	BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
DIN EN ISO 8638 E : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
I.S. EN ISO 23908:2013	SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011)
BS EN ISO 6710 : 2017	SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
16/30316718 DC : 0	BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
13/30283694 DC : 0	BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
I.S. EN ISO 18113-2:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
DIN EN ISO 5367:2015-02	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
16/30331653 DC : 0	BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 22413:2013	TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS (ISO 22413:2010)
ISO 11195:2018	Gas mixers for medical use Stand-alone gas mixers
16/30346835 DC : 0	BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
16/30340242 DC : 0	BS IEC 60601-2-4 ED3.0 AMD 1 - EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
CSA Z8836 : 2011 : FR	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 20072 : 2013	AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
UNI EN ISO 21563 : 2013	DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
AAMI ISO 16142-2 : 2017	MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
UNI EN ISO 3630-5 : 2012	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS
BS EN ISO 21531:2009 (published 2009-03)	Dentistry. Graphical symbols for dental instruments
BS ISO 81060-1 : 2007 COR 2012	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
16/30302520 DC : 0	BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
UNE-EN ISO 18113-3:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
CAN/CSA-C22.2 NO. 80601-2-72:17	Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
I.S. EN ISO 10555-1:2013	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
BS EN 1865-2 : 2010	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
UNE-EN ISO 18113-2:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
BS EN ISO 10079-1:2015	MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT
CAN/CSA-Z10524-4:12 (R2017)	Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations)
ISO/TS 17137:2014	Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
I.S. EN ISO 3826-4:2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
CSA Z10524-4 : 2012	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
NF EN ISO 80601-2-12 : 2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
CSA C22.2 No. 60601.2.49:2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
UNI EN ISO 8836 : 2015	A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNE-EN ISO 8836:2015	Suction catheters for use in the respiratory tract (ISO 8836:2014)
CSA ISO 8638 : 2012 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 8637 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
CSA C22.2 No. 80601-2-56 : 2012 : R2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
CSA ISO 16628 : 2014	TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
ISO 14708-2:2012	Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
EN ISO 3630-3 : 2015	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 3: COMPACTORS: PLUGGERS AND SPREADERS (ISO 3630-3:2015)
CSA ISO 8637 : 2012	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
CSA Z17510.1 : 2010	SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
I.S. EN ISO 1135-3:2017	TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
AAMI ISO 14708-4 : 2008 : R2011	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
16/30328610 DC : 0	BS ISO 20749 - DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
UNI EN ISO 18113-3 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
I.S. EN ISO 9687:2015	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
BS EN ISO 16061:2015	INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
AAMI ISO 14708-4 : 2008	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
BS EN 60601-2-4:2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
BS ISO 16628:2008 (published 2009-04)	Tracheobronchial tubes. Sizing and marking
I.S. EN 60601-2-4:2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
UNE-EN ISO 12417-1:2016	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
ISO/TR 12417-2:2017	Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 2: Local regulatory information
DIN EN ISO 22413:2013-10	Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN ISO 80601-2-12:2011	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
CSA Z8836 :2011	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
DIN EN ISO 18113-2:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
CSA Z8836 : 2011 : R2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CAN/CSA-ISO 11138-1:17	Sterilization of health care products Biological indicators Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
PREN ISO 11978 : DRAFT 2013	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO/DIS 11978:2013)
AAMI ISO 13958 : 2009	CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES
BS EN ISO 10555-1 : 2013	INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 5361:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
I.S. EN 61010-2-101:2017	SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
CSA ISO 8637 : 2012 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
DIN EN ISO 21563:2013-12	Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
DIN EN ISO 3630-5:2012-01	DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
UNE-EN ISO 80601-2-69:2015	Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
PREN 868-5 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
UNI EN ISO 13079 : 2011	LABORATORY GLASS AND PLASTICS WARE - TUBES FOR THE MEASUREMENT OF THE ERYTHROCYTE SEDIMENTATION RATE BY THE WESTERGREN METHOD
AAMI ISO 12417-1 : 2015	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
ISO 80601-2-56:2017	Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
UNE-EN ISO 21563:2014	Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
I.S. EN ISO 28319:2010	DENTISTRY - LASER WELDING AND FILLER MATERIALS (ISO 28319:2018)
UNE-EN ISO 80601-2-56:2013	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
ISO 12891-1:2015	Retrieval and analysis of surgical implants Part 1: Retrieval and handling
CEI UNI EN 15986 : 2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
ISO 10650:2015	Dentistry Powered polymerization activators
I.S. EN 16844:2017+A2:2019	Aesthetic medicine services - Non-surgical medical treatments
ISO 5910:2018	Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
I.S. EN 60601-1-11:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
CSA C22.2 No. 80601-2-55 : 2014(R2019)	MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
AAMI 13958 : 2014	CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES
PREN 13795-2 : DRAFT 2017	SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
I.S. EN ISO 12836:2015	DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY (ISO 12836:2015)
ISO 80601-2-67:2014	Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
BS EN ISO 17664:2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
BS PD IEC TR 60601-4-3 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 4-3: GUIDANCE AND INTERPRETATION - CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE THIRD EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS
UNI EN ISO 8638 : 2014	CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
CSA C22.2 No. 80601-2-69 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
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
BS EN 60601-2-49:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT
UNE-EN ISO 20072:2013	Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
BS EN ISO 11070 : 2014	STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
CSA C22.2 No. 60601-1-12 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
NBR ISO 25841 : 2015	FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
AAMI ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
UNE-EN ISO 14155:2012	Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NBR ISO 10651-5 : 2017	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
I.S. EN ISO 21531:2009	DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS
I.S. EN ISO 11978:2017	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017)
ISO 18397:2016	Dentistry Powered scaler
I.S. EN ISO 26782:2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
I.S. EN ISO 22413:2013	TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS (ISO 22413:2010)
EN 60601-1-11 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
I.S. EN ISO 18113-5:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
I.S. EN ISO 80601-2-55:2018