YY 0167-2020Non-absorbable surgical suture (English PDF)

Foreword

All technical contents of this Standard are mandatory.

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces YY 0167-2005, Non-absorbable surgical suture; the main technical changes, except editorial changes, are as follows.

-- Add the non-application scope of the standard (see Chapter 1);

-- Modify the classification of sutures (see Chapter 3; Chapter 3 of version

2005);

-- Add the expression of a single value of suture diameter (see Table 2, Table 2 of version 2005);

-- Modify the names of breaking strength and connection strength (see 4.3 and 4.4; 4.3 and 4.4 of version 2005);

-- Add the expression of the single value of the suture breaking strength (see Table 3; Table 3 of version 2005);

-- Modify the color fading requirements (see 4.5; 4.5 of version 2005);

-- Modify the length requirements (see 4.6; 4.6 of version 2005);

-- Delete the requirements of suture needles (see 4.7 of version 2005);

-- Modify the description of biological evaluation (see 4.9 and 5.9; 4.10 and 5.10 of version 2005);

-- Add the requirements and test methods for the marking of Class-B sutures (see 4.10 and 5.10);

-- Modify the suture diameter test method (see Appendix A of 5.2; 5.2 of version 2005);

-- Modify the test methods for breaking strength and needle and suture connection strength (see Appendix B of 5.3 and 5.4; 5.3 and 5.4 of version

2005);

-- Modify the type inspection (see Chapter 6; Chapter 6 of version 2005);

-- Add requirements for labels and instructions (see Chapter 7; Chapter 7 of version 2005);

-- Modify the suture storage and transportation conditions and validity period (see 8.5; 8.4 of version 2005).

This Standard refers to U. S. Pharmacopoeia 38 and European Pharmacopoeia 8.0.

1 Scope

This Standard specifies the classification, requirements, test methods, type inspections, labels, instructions, packaging, transportation, storage and validity period of non-absorbable surgical suture.

This standard applies to non-absorbable surgical suture (hereinafter referred to as suture) for suturing and ligating human tissues.

This Standard does not apply to specially designed non-absorbable surgical suture.

2 Normative references

The following documents are indispensable for the application of this document.

For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191, Packaging - Pictorial marking for handling of goods

GB/T 8170, Rules of rounding off for numerical values & expression and judgment of limiting values

GB/T 9737-2008, Chemical reagent - General rules for the determination of readily carbonizable substances

GB/T 9969, General principles for preparation of instructions for use of industrial products

GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods

GB/T 16886, Biological evaluation of medical devices

3 Classification of suture

4 Requirements

5 Test method

6 Type inspection

The type inspection items and sample size of the suture are shown in Table 5. All inspection items shall be qualified.

7 Labels, instructions

8 Packaging, transportation, storage and validity period

8.1 The single package shall be the minimum package available for use. Sterilized sutures remain sterile during the validity period.

8.2 After the single package is opened, there shall be traces of opening.

8.5 The storage and transportation conditions and validity period of the suture shall be specified by the manufacturer.