BS EN 1422:2014
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
- Standard No.
- BS EN 1422:2014
- Release Date
- 2014
- Published By
- British Standards Institution (BSI)
- Latest
- BS EN 1422:2014
- Replace
- BS EN 1422:1997+A1:2009
BS EN 1422:2014 Referenced Document
- 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
- EN 1041 Information supplied by the manufacturer of medical devices
- EN 13445-3 Unfired pressure vessels - Part 3: Design
- EN 13445-5 Unfired pressure vessels - Part 5: Inspection and testing
- EN 14222 Stainless steel steam boilers*， 2020-12-31 Update
- EN 1837 Safety of machinery - Integral lighting of machines*， 2020-11-30 Update
- EN 60204-1:2006 Safety of machinery - Electrical equipment of machines Part 1: General requirements (Incorporates Amendment A1: 2009; Incorporating corrigendum February 2010)
- EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2023-12-23 Update
- EN 61010-2-040:2005 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 61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 1: General requirements (Incorporating corrigenda February 2008 and February 2010; Remains Current)
- EN 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements
- EN 764-7 Pressure equipment - Part 7: Safety systems for unfired pressure equipment
- 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 868-4 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods*， 2017-02-01 Update
- 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*， 2018-12-01 Update
- EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)*， 2023-12-23 Update
- EN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements*， 2017-03-01 Update
- EN ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes*， 2017-03-01 Update
- EN ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
- EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- 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)*， 2023-12-23 Update
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements*， 2017-02-28 Update
- ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes*， 2017-03-01 Update
- ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
- ISO 14971:2007 Medical devices - Application of risk management to medical devices
- 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
BS EN 1422:2014 history
- 2014 BS EN 1422:2014 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
- 1998 BS EN 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
- 1990 BS 3970-1:1990 Sterilizing and disinfecting equipment for medical products - Specification for general requirements
