BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

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 Validation of packaging processing
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) - Process development
Annex B (informative) - Draft guidance on the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Annex C (informative) - Draft guidance on the relationship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 11607-2.

Committee	CH/198
DocumentType	Draft
Pages	29
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
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
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO/TS 16775:2014	Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
AAMI ST65:2008(R2018)	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
ISO 186:2002	Paper and board — Sampling to determine average quality
DIN 58953-8:2010-05	STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
DIN 58953-7:2010-05	STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS
AAMI ST77 : 2013	CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
DIN 58953-9:2010-05	Sterilization - Sterile supply - Part 9: Use of sterilization container