GB/T 25440.1-2021Retrieval and analysis of surgical implants - Part 1: Retrieval and handling (English PDF)

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).

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