YY/T 0171-2008Surgical instruments - Packaging, Marking and Instructions (English PDF)
外科器械 包装、标志和使用说明书
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 17, 2008
Implementation date
January 1, 2010
Scope
YY/T 0171-2008 is the English-translated version of 外科器械 包装、标志和使用说明书.
YY/T 0171-2008 is the Chinese pharmaceutical industry standard for the packaging, labelling and instructions for use of surgical instruments.
It covers three kinds of packaging: ordinary packaging, with rust prevention, protection of sharp tips and edges, non-toxic sealed primary packs and the certificate in the outer pack; sterilization packaging; and aseptic packaging, where each single-use product is separated, the pack stays sterile until opened and must be used at once and discarded if damaged.
It then fixes the markings on each kind of pack and the content of the instructions for use. Compared with the 1994 edition it adds sterilization and aseptic packaging and takes its present title. Issued on 17 October 2008, it has applied since 1 January 2010.
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Document preview — YY/T 0171-2008
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
- Replacing
- YY/T 0171-1994
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Packaging
- 4 Flag
Foreword
Instead of the standard YY/T 0171-1994 "surgical instruments, packaging technology." Compared with the standard YY/T 0171-1994 The main changes are as follows.
--- Expanding the scope of the package, increasing the sterilization packaging and aseptic packaging requirements;
--- NORM packaging, packaging logo;
--- Renamed "surgical instrument packaging, labeling and instructions for use." The standard surgical instrument by the National Standardization Technical Committee and centralized.
This standard by the Shanghai Medical Devices (Group) Co., Ltd. Surgical Instrument Factory, Shanghai Medical device testing is responsible for drafting.
1 Scope
This standard specifies the surgical instrument products packaging, labeling and instructions for use.
This standard applies to general surgical instruments products packaging, sterilization packaging and aseptic packaging.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9969.1 Instructions General Industrial Products
YY 0466 medical equipment used with medical device labels, signs and symbols provide information (YY 0466-2003, ISO 15223. 2000, IDT)
3 Packaging
3.1 Ordinary packaging
Rust treatment can be carried out before cleaning or 3.1.1 product packaging to ensure that the product during storage does not produce corrosion phenomenon.
3.1.2 sharp head end or front port products before packaging products protective response processing, and packaging of the product from damage.
3.1.3 Type of packaging should ensure that products are not affected in normal storage and transportation process.
3.1.4 primary package may be a single piece individually wrapped or packaged with equipment package type.
First 3.1.5 package should be used on the human body non-toxic materials, packaging materials and the reaction should not occur with the contents. Single primary package should be sealed, not We must have a cracking phenomenon. Package equipment package instrument should be firmly fixed.
3.1.6 by the beginning of packaged products, single or same type, with the specifications of pieces outer packaging together with the certificate. Equipment package can be qualified Card directly into the outer package.
3.1.7 After packaging the product can be carried out after the transport packaging.
3.2 Sterilization packaging
3.2.1 Sterilization packaging shall comply with the general packaging requirements 3.1.2 ~ 3.1.7.
3.2.2 disinfection products should ensure that the primary package contents from contamination prior to the expiration date and easily opened.
3.2.3 Disinfection products disinfection process should be conducive to the primary package contents chosen.
3.3 Aseptic Packaging
3.3.1 Aseptic packaging shall comply with the general packaging requirements 3.1.2 ~ 3.1.7.
3.3.2 sterile products primary package is the smallest package for one-time use, if a plurality of the same specifications of the products packaged in the same package, each A product shall be separated from each other.
3.3.3 sterile product packaging should be sealed, and to ensure that the product before sterilization expiration date sterile until opened.
3.3.4 Aseptic packaging once opened should be used immediately. Disposable products prohibit secondary use, and should be noticeable warning signs.
3.3.5 Once damaged aseptic packaging should be strictly prohibited.
4 Flag
4.1 Package Marking
4.1.1 Ordinary packaging logo
General packaging shall be marked with instructions.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
GB 9969.1
Similar standards
Editions of YY/T 0171
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0171-2008 | Surgical instruments - Packaging, Marking and Instructions | current edition | Current |
| YY/T 0171-1994 | Surgical instruments - Packaging, Marking and Instructions | previous edition | Superseded |
This page sells the current edition, YY/T 0171-2008. Earlier editions are listed for reference only.
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