BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials, preformed sterile barrier systems and
   sterile barrier systems
6 Design and development for packaging systems
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
9 Design changes and revalidation
10 Inspection of sterile medical devices packages
   immediately prior to aseptic presentation
11 Information to be provided
Annex A (informative) - Guidance on medical
        packaging
Annex B (informative) - Standardized test methods,
        guides and procedures that may be used to demonstrate
        compliance with the requirements of this part of ISO 11607
Annex C (normative) - Test method for defining impermeable
        materials to the passage of air
Annex D (informative) - Environmental aspects
Annex E (informative) - Draft guidance on the relationship
        between this standard and the general safety and
        performance requirements of Regulation (EU) 2017/745
        of the European Parliament and of the Council of
        5 April 2017 on medical devices, amending Directive
        2001/83/EC, Regulation (EC) No 178/2002 and
        Regulation (EC) No 1223/2009 and repealing Council
        Directives 90/385/EEC and 93/42/EEC
Annex F (informative) - Draft guidance on the relationship
        between this standard and general safety and performance
        requirements of Regulation (EU) 2017/746 of the European
        Parliament and of the Council of 5 April 2017 on in vitro
        diagnostic medical devices and repealing Directive
        98/79/EC and Commission Decision 2010/227/EU
Annex ZA (informative) - Relationship between this European
         Standard and the essential requirements of Directive
         93/42/EEC [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 90/385/EEC [OJ L 189] aimed to be covered
Annex ZC (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 98/79/EC [OJ L 331] aimed to be covered
Bibliography

BS EN ISO 11607-1.

Committee	CH/198
DocumentType	Draft
Pages	55
PublisherName	British Standards Institution
Status	NA

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
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
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 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
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 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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
AAMI ST65:2008(R2018)	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
ISO 5636-5:2013	Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
ISO 186:2002	Paper and board — Sampling to determine average quality
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ANSI/AAMI ST79:2017	COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI ST77 : 2013	CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
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 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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