ISO 8828:2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
16-07-2021
English
10-11-2014
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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Withdrawn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 |
| 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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