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GB/T 25440.1-2021: Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
Status: Valid GB/T 25440.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 25440.1-2021 | English | 404 |
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Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
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GB/T 25440.1-2021
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| GB/T 25440.1-2010 | English | 914 |
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Retrieval and analysis of surgical implants -- Part 1: Retrieval and handling
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GB/T 25440.1-2010
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PDF similar to GB/T 25440.1-2021
Basic data | Standard ID | GB/T 25440.1-2021 (GB/T25440.1-2021) | | Description (Translated English) | Retrieval and analysis of surgical implants - Part 1: Retrieval and handling | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 23,219 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 25440.1-2021: Retrieval and analysis of surgical implants - Part 1: Retrieval and handling---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Retrieval and analysis of surgical implants - Part 1.Retrieval and handling
ICS 11.040.40
C45
National Standards of People's Republic of China
Replace GB/T 25440.1-2010
Removal and analysis of surgical implants
Part 1.Take-out and disposal
(ISO 12891-1.2015, IDT)
Released on 2021-11-26
2022-12-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
1 Scope 1
2 Terms and definitions 1
3 Method 1
4 Take out adjacent tissues and body fluids for analysis 7
5 Infection Control 7
Appendix A (informative appendix) It is recommended to record the minimum information related to the removal of surgical implants 11
Appendix B (informative appendix) General procedures for removing surgical implants for sterilization 13
Appendix C (informative appendix) Take out tissue samples and analysis of body fluids 17
Reference 18
Foreword
GB/T 25440 "Removal and Analysis of Surgical Implants" is divided into two parts.
---Part 1.Take out and handle;
---Part 2.Analysis of the removal of surgical implants.
This part is Part 1 of GB/T 25440.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 25440.1-2010 "Removal and Analysis of Surgical Implants Part 1.Removal and Processing", and
Compared with GB/T 25440.1-2010, in addition to editorial changes, the main technical changes are as follows.
---Modified the scope of application of the standard (see Chapter 1, Chapter 1 of the.2010 edition);
--- Deleted "inclusions" (see 2.2 in the.2010 edition), "biological products" (see 2.3 in the.2010 edition), and "clinical samples" (see.2010
The terms of 2.4), “medical waste” (see 2.6 in.2010), “refrigeration materials” (see 2.7 in.2010), and
definition;
--- Modified clinical medical records (see 3.1, 3.2 in.2010 edition), collection of surgical implants (see 3.3, 3.7.2 in.2010 edition), group
Tissue and body fluid sample collection (see 3.4,.2010 version 3.6), removal of surgical implants, tissue, body fluid labels (3.6,.2010
Version 3.7.3), cleaning of removing surgical implants (see 3.7,.2010 version 4.2.3) and disinfection (3.8,.2010 version
4.2.4), the packaging of the implant, tissue, and body fluid to be transported (see 3.9, 4.3 in the.2010 edition), and the surgical implant is attached
The content of the document (3.12,.2010 version 4.3.2.5), the image record of the removal activity (see 3.5), and the cleaning after transportation have been added.
And documentation during disinfection (see 3.14), inspection, analysis and storage (see 3.15);
---Modified the content of "Removing adjacent tissues and analysis of body fluids" (see Chapter 4, Chapter 5 of the.2010 Edition);
---Added "If you need to incinerate human waste, you should put the waste in a leak-proof, flammable container, and mark the'harmful biological waste
Junk'" (see 5.5.1).
The translation method used in this part is equivalent to ISO 12891-1.2015 ``Removal and Analysis of Surgical Implants Part 1.Removal and Disposal
reason".
This section has made the following editorial changes.
--- Added "This part is applicable to the removal of surgical implants and related tissues and body fluids" in the scope, which improves the application of this document
Use boundaries;
--- Replace ISO 12891-2 with GB/T 25440.2, which is equivalent to the international standard (see note in Chapter 4).
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC110).
Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China) Co., Ltd., Beijing Natongke
Technology Group Co., Ltd.
The main drafters of this section. Li Libin, Li Jia, Li Yuan, Chen Changsheng, Yang Qun, Dong Xiang, Li Mei.
The previous releases of the standards replaced by this part are as follows.
---GB/T 25440.1-2010.
Removal and analysis of surgical implants
Part 1.Take-out and disposal
1 Scope
This part of GB/T 25440 specifies the method of removal and disposal of surgical implants and related tissues and body fluids. In particular, the headquarters
It specifies the necessary steps for the safe and correct acquisition of clinical medical records, inspection before removal, collection, marking, cleaning, disinfection, recording, packaging and transportation.
This section also provides guidance and recommendations for infection control.
This section applies to the removal of surgical implants and related tissues and body fluids.
This section does not apply to unintentional collection and retrieval activities, but such activities can use the practical information provided in the relevant provisions of this section.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Absorbent
Material that can absorb liquids.
Note. It can be particulate or non-particulate materials.
2.2
Contamination
Unexpected addition of substances or changes to the sample, including exposure to potential sources of infection.
2.3
Infectious waste
Waste that contains or may contain pathogenic microorganisms that cause disease in the human body.
2.4
Outer shipping container
The outermost container used for the final shipping package.
2.5
Primary container
Tubes, sealed bags, or other impervious containers used to contain transport materials.
2.6
Secondary container(s)
The container used to hold the primary container.
3 method
3.1 Obtaining the implant and the patient's clinical medical records
The clinical history of patients and surgical implants should be obtained and recorded as much as possible. The medical record should contain at least the following.
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