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ISO 12891-1:2015 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling >
ISO 12891-1:2015 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling, 2015
- Foreword
- Introduction
- 1 Scope
- 2 Terms and definitions
- 3 Method
- 3.1 Obtaining the clinical history of the implant and patient
- 3.2 Pre-explantation checks and examinations
- 3.3 Collecting the surgical implant
- 3.4 Collecting the tissue and fluid samples
- 3.5 Photographic record of the explantation
- 3.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for future identification
- 3.7 Cleaning the retrieved surgical implant
- 3.8 Decontaminating the retrieved surgical implant
- 3.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment
- 3.10 Use of coolant materials
- 3.11 Labelling of the packing materials
- 3.12 Documentation to be supplied with retrieved surgical implants
- 3.13 Unpacking following shipment
- 3.14 Cleaning and decontamination following shipment
- 3.15 Documentation to be maintained during examination, analysis, and storage
- 4 Analysis of retrieved surrounding tissues and fluids
- 5 Infection control
- 5.1 General
- 5.2 Work practices
- 5.3 Personal protective equipment
- 5.3.1 General
- 5.3.2 Gloves
- 5.3.3 Masks, eye protection, and face shields
- 5.3.4 Gowns, aprons, and other protective body clothing
- 5.4 Maintenance of the worksite
- 5.4.1 Cleaning and disinfection of worksites
- 5.4.2 Protective coverings
- 5.4.3 Equipment and tools
- 5.4.4 Reusable receptacles
- 5.4.5 Contaminated glassware
- 5.4.6 Reusable items
- 5.4.7 Contaminated materials
- 5.5 Human waste disposal
- 5.6 Special practices
- Annex A (informative) Suggested minimum information to be obtained for retrieved surgical implants
- Annex B (informative) Generic procedures for the decontamination of surgical implants
- Annex C (informative) Analyses to be performed on retrieved tissue samples and fluids
- Bibliography [Go to Page]