12/30262894 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
31-05-2014
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power and vibration
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test methods
Annex B (normative) - Sterilizer classification and testing
Annex C (normative) - Test equipment
Annex D (normative) - Determination of formaldehyde residuals
in a filter indicator
Annex E (informative) - Formaldehyde residues on medical devices
Annex F (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European Standard
and the Essential Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography
BS EN 14180.
Committee |
LBI/35
|
DocumentType |
Draft
|
Pages |
62
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
PREN 14180 : DRAFT 2012 | Identical |
IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
EN 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
EN 60584-2:1993 | Thermocouples - Part 2: Tolerances |
EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
EN 61672-2:2013/A1:2017 | ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017) |
ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
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 |
EN 1837:1999+A1:2009 | Safety of machinery - Integral lighting of machines |
IEC 60204-1:2016 | Safety of machinery - Electrical equipment of machines - Part 1: General requirements |
ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
EN 867-5:2001 | Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
EN 868-6:2017 | Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods |
EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
ISO 12100:2010 | Safety of machinery — General principles for design — Risk assessment and risk reduction |
EN 868-2:2017 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
EN ISO 228-1:2003 | Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) |
EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
EN 61326-1:2013 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
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 |
EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
EN 764-7:2002/AC:2006 | PRESSURE EQUIPMENT - PART 7: SAFETY SYSTEMS FOR UNFIRED PRESSURE EQUIPMENT |
IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
EN 61672-1:2013 | Electroacoustics - Sound level meters - Part 1: Specifications |
EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
EN ISO 3746:2010 | Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010) |
EN 60751:2008 | INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS |
ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
EN 62061:2005/A2:2015 | SAFETY OF MACHINERY - FUNCTIONAL SAFETY OF SAFETY-RELATED ELECTRICAL, ELECTRONIC AND PROGRAMMABLE ELECTRONIC CONTROL SYSTEMS (IEC 62061:2005/A2:2015) |
ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
IEC 60751:2008 | Industrial platinum resistance thermometers and platinum temperature sensors |
ISO 9001:2015 | Quality management systems — Requirements |
EN ISO 12100:2010 | Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010) |
EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
EN ISO 13849-1:2015 | Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design (ISO 13849-1:2015) |
ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
EN 14222:2003 | Stainless steel shell boilers |
EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
EN ISO 17665-1 : 2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
IEC 61508-1:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508) |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
EN ISO 10012:2003 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
IEC 62061:2005+AMD1:2012+AMD2:2015 CSV | Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems |
IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
CEN ISO/TS 11135-2:2008/AC:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
ISO 13849-1:2015 | Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design |
EN 980:2008 | Symbols for use in the labelling of medical devices |
ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
EN 868-7:2017 | Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods |
ISO 228-1:2000 | Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation |
EN ISO 11138-5:2017 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
1997/23/EC : 1997 | DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT |
EN 60204-1 : 2006 COR 2010 | SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.