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ISO 8828:2014

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Implants for surgery Guidance on care and handling of orthopaedic implants
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

07-16-2021

Language(s)

English

Published date

11-10-2014

Publisher

International Organization for Standardization

ISO 8828:2014 specifies the recommended procedures for handling orthopaedic implants, hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded.

This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements.

This guidance does not apply to the implant manufacturer. However, it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers.

DevelopmentNote
Supersedes ISO/DIS 8828. (11/2014)
DocumentType
Standard
Pages
6
PublisherName
International Organization for Standardization
Status
Withdrawn
Supersedes

Standards Relationship
BS ISO 8828:2014 Identical
AS ISO 8828:2015 Identical
NEN ISO 8828 : 2014 Identical
IS 11034 : 2019 Identical
BS 3531-17:1985 Similar to
DIN 58800-1:1983-11 (Draft) Similar to
BIS IS 11034 : 1993(R2017) Identical
I.S. ISO 8828:1991 Identical
NF ISO 8828 : 1989 Identical
NEN NPR ISO 8828 : 1989 Identical

DIN EN ISO 21534 E : 2009 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
BS EN 12010:1998 Non-active surgical implants. Joint replacement implants. Particular requirements
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
I.S. EN 12010:1998 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
DIN EN ISO 21534:2009-08 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
UNI EN ISO 21534 : 2009 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
BS EN ISO 21534:2009 Non-active surgical implants. Joint replacement implants. Particular requirements
I.S. EN ISO 21534:2009 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
ISO 21534:2007 Non-active surgical implants Joint replacement implants Particular requirements
EN 12010 : 1998 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

ASTM F 565 : 2004 : R2009 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ISO 14630:2012 Non-active surgical implants General requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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