YY/T 0587-2018Sterile dental injection needles for single use (English PDF)

Foreword

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

This standard replaces YY 0587-2005 "disposable sterile dental injection needle". Compared with YY 0587-2005, except for editorial repair The main technical changes changed are as follows.

--- Revised the definition of "cylinder dental syringe" in Chapter 1, "Scope";

---Modified Figure 1 "Hard Packing Dental Needle Schematic";

---Modified the contents of the threaded needle type and marking example in Chapter 4, "Product Marking";

--- Move the type of Wyeth internal threaded hub in Chapter 4 "Product Marking" to Appendix C of this standard;

--- Increased the 0.2mm specification in Table 1;

--- Modified 6.6 tip;

--- Modified 7.3 extractable metal content;

--- Modified 8.3 bacterial endotoxin;

--- Removed the terms of the 10.3 User's Guide;

--- Removed the schematic diagram of Appendix A flow test device;

--- Revised the preparation of Appendix C biological test test solution;

--- Removed the Appendix D inspection rules.

This standard uses the redrafting method to modify the use of ISO 7885:2010 "disposable sterile dental needles." The technical differences between this standard and ISO 7885:2010 and their reasons are as follows.

---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments The situation is reflected in Chapter 2, "Regulatory References", and the specific adjustments are as follows.

- Replace ISO 9626 with GB/T 18457 modified to international standards (see Chapter 5);

- Added reference to GB/T 14233.1 (see 7.2, 7.3);

- Added reference to GB/T 14233.2 (see 8.2, 8.3);

- Replace ISO 10993-1 with GB/T 16886.1 equivalent to the international standard (see 8.2);

- Replace ISO 15233-1 (10.1, 10.2) with YY/T 0466.1, which is equivalent to the international standard;

- Added reference to GB/T 6682 (see Appendix B).

--- Added "Chapter 4 Product Marking" to standardize product marking requirements;

--- Added "6.6 first bevel angle of the puncture end" to clarify the requirements of the first bevel angle of the puncture end;

--- Added "6.3 pinhole smoothness";

--- Added "6.5.4 Needle tube characteristics", the needle tube characteristics are an important factor to investigate the safety performance of the needle tube material, thus increasing the needle tube Sex indicator --- Increased 7.2 "pH";

--- Added 8.3 "bacterial endotoxin". This standard has made the following editorial changes.

--- Added Appendix B (normative appendix) "Preparation of chemical test solution";

--- Added Appendix C (Normative Appendix) "Preparation of Bacterial Endotoxin Test Solution".

1 Scope

This standard specifies the terms and definitions, requirements, packaging, marking and storage of disposable sterile dental injection needles (hereinafter referred to as dental needles). Deposit requirements.

This standard applies to dental needles installed on dental card syringes conforming to the ISO 9997 standard for dental local anesthesia, but not Dental needles for special applications and technologies.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696:1987. MOD)

GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1

GB/T 14233.2 Methods of test for infusions, blood trans

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- 2011, ISO 10993-1.:2009, IDT)

GB/T 18457 Stainless steel needle tube for medical devices (GB/T 18457-2015, ISO 9626:1991/Amd.1.2001) MOD)

YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1. General requirements (YY/T 0466.1-2016, ISO 15233-1:2012, IDT)

ISO 9997 dental card syringe The Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document.