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YY/T 0171-2008: Surgical instruments. Packaging, Marking and Instructions YY/T 0171: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0171-2008 | English | 209 |
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Surgical instruments. Packaging, Marking and Instructions
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YY/T 0171-2008
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| YY/T 0171-1994 | English | 199 |
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General technical requirements for pack of surgical instruments
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YY/T 0171-1994
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PDF similar to YY/T 0171-2008
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Count Estimation | 6,645 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Older Standard (superseded by this standard) | YY/T 0171-1994 | | Quoted Standard | GB 9969.1; YY 0466 | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State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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