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BS EN 868-1:1997

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods
Available format(s)

Hardcopy , PDF

Withdrawn date

26-10-2018

Language(s)

English

Published date

15-12-1997

Publisher

British Standards Institution

1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Documentation
7 Information
Annex A (informative) Guidance on clause 4
Annex B (informative) Microbial barrier evaluation scheme
Annex C (informative) Air impermeability - Test methods
Annex D (informative) Microbial barrier properties -
        Test methods for materials
Annex E (informative) Microbial barrier properties -
        Test methods for permeable closures (filter assembly,
        tortuous path)
Annex F (informative) Impermeability and continuity of seals
        formed by fusion or adhesion - Test methods
Annex G (informative) Impermeability of seals not formed by
        fusion or adhesion - Test methods - Test procedure
        for rigid containers
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
        addressing essential requirements or other provision
        of EU Directives

Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.

Committee
CH/198
DevelopmentNote
Supersedes 92/58621 DC. (08/2005)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy
Supersedes

Standards Relationship
EN 868-1 : 1997 Identical
UNI EN 868-1 : 1999 Identical
DIN EN 868-1:1997-05 Identical
I.S. EN 868-1:1997 Identical
NBN EN 868-1 : 1997 Identical
NS EN 868-1 : 1ED 1997 Identical
UNE-EN 868-1:1997 Identical
NEN EN 868-1 : 1997 Identical
SN EN 868-1 : 1997 Identical
NF EN 868-1 : 1997 Identical

BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes General requirements

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
PREN 868-8 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
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
ISO 5636-2:1984 Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
ISO 5636-5:2013 Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ASTM F 1608 : 2016 : REDLINE Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
PREN 868-2 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
PREN 868-4 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
ISO 9001:2015 Quality management systems — Requirements
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
ISO 11607:2003 Packaging for terminally sterilized medical devices
BS 6255:1989 Specification for plain sterilization paper for medical use
PREN 868-7 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
PREN 868-3 : DRAFT 2015 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
PREN 868-6 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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PDF - English
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