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BS ISO 28620:2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices. Non-electrically driven portable infusion devices
Available format(s)

Hardcopy , PDF

Superseded date

01-20-2020

Language(s)

English

Published date

02-28-2010

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Operating requirements
6 Test methods
7 Information to be listed on packaging and/or product
8 Accompanying documents
Bibliography

Describes essential requirements and related test methods for non-electrically driven portable infusion devices.

Committee
CH/212
DevelopmentNote
Supersedes 08/30170025 DC. (09/2010)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 28620:2010 Identical

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 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
ISO 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN 13868:2002 Catheters - Test methods for kinking of single lumen catheters and medical tubing
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

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Hardcopy - English
PDF - English
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