YY/T 0171-2008 English PDF

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YY/T 0171-2008: Surgical instruments. Packaging, Marking and Instructions

YY/T 0171: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0171-2008	209	Add to Cart	3 days	Surgical instruments. Packaging, Marking and Instructions
YY/T 0171-1994	199	Add to Cart	2 days	General technical requirements for pack of surgical instruments	Obsolete

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Basic data

Standard ID: YY/T 0171-2008 (YY/T0171-2008)
Description (Translated English): Surgical instruments. Packaging, Marking and Instructions
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 6,645
Date of Issue: 2008-10-17
Date of Implementation: 2010-01-01
Older Standard (superseded by this standard): YY/T 0171-1994
Quoted Standard: GB 9969.1; YY 0466
Regulation (derived from): SFDA [2008] No. 605
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the surgical equipment products in packaging, labeling and instructions for use. This standard applies to ordinary surgical equipment products packaging, sterilization packaging and aseptic packaging.

YY/T 0171-2008: Surgical instruments. Packaging, Marking and Instructions

---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.
Surgical instruments.Packaging, Marking and Instructions ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Replacing YY/T 0171-1994 Surgical instrument packaging, labeling and instructions for use Posted 2008-10-17 2010-01-01 implementation State Food and Drug Administration issued

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. The main drafters of this standard. Liu Wei group, Ni Zhidi. This standard replaces the standards previously issued as follows. --- YY/T 0171-1994; --- WS2/Z-2-1964. Surgical instrument packaging, labeling and instructions for use

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. ......

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