HOME   Cart(0)   Quotation   About-Us Tax PDFs Standard-List Powered by Google www.ChineseStandard.net Database: 189759 (5 Jan 2025)

YY/T 0313-2014 English PDF (YY/T 0313-1998)

YY/T 0313-2014_English: PDF (YY/T0313-2014)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0313-2014English115 Add to Cart 0--9 seconds. Auto-delivery Medical polymer products. Requirement for package and information supplied by manufacturer Valid YY/T 0313-2014
YY/T 0313-1998English85 Add to Cart 0--9 seconds. Auto-delivery Package, lable, transport and storage for medical polymer products Obsolete YY/T 0313-1998


BASIC DATA
Standard ID YY/T 0313-2014 (YY/T0313-2014)
Description (Translated English) Medical polymer products. Requirement for package and information supplied by manufacturer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.080.040
Word Count Estimation 14,196
Date of Issue 2014/6/17
Date of Implementation 2015/7/1
Older Standard (superseded by this standard) YY/T 0313-1998
Quoted Standard GB/T 3102.1; GB/T 3102.2; GB/T 3102.3; GB/T 3102.4; GB/T 3102.5; GB/T 3102.6; GB/T 3102.7; GB/T 3102.8; GB/T 3102.9; GB/T 3102.10; GB/T 3102.11; GB/T 3102.12; GB/T 3102.13; GB/T 4892; GB/T 6543; GB/T 7408; GB/T 19633.1; YY/T 0466.1; YY/T 0468; YY/T 1119
Drafting Organization Shandong Province Quality Inspection Center for Medical Devices
Administrative Organization National Standardization Technical Committee infusion
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to medical polymer product packaging and labeling. This Standard specifies the packaging and manufacturers of medical polymer products provide information on request.

BASIC DATA
Standard ID YY/T 0313-1998 (YY/T0313-1998)
Description (Translated English) Package, lable, transport and storage for medical polymer products
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C48
Word Count Estimation 11,165
Date of Issue 1998/8/27
Date of Implementation 1998/10/1
Older Standard (superseded by this standard) ZB C48006-1989
Quoted Standard GB 191-1990; GB 4892-1985; GB 6543-1986
Drafting Organization State Pharmaceutical Administration Medical Polymer Products Quality Inspection Center
Administrative Organization State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the medical polymer products, packaging, labeling, transportation and storage. This standard applies to medical polymer products, packaging, labeling, transportation and storage. Special products specified by the product standards.


YY/T 0313-2014 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.040 C 30 Replacing YY/T 0313-1998 Medical polymer products - Requirement for package and information supplied by manufacturer ISSUED ON. JUNE 17, 2014 IMPLEMENTED ON. JULY 1, 2015 Issued by. China Food and Drug Administration 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes. Table of Contents Foreword ... 3  1 Scope ... 5  2 Normative references ... 5  3 Terms and definitions ... 6  4 Product classification ... 8  5 Package requirements ... 8  6 Requirements for the information supplied by the manufacturer ... 12  Annex A (Informative) Guidelines for the information of medical devices required to be supplied for meeting the requirements of EU Council Directive 93/42/EEC ... 16  References ... 23  Foreword This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces the YY/T 0313-1998 Package, label, transport and storage for medical polymer products. Compared with YY/T 0313-1998, the major changes in this Standard are as follows. — MODIFY the standard name; — MODIFY the “Scope” applicable to this Standard (SEE Chapter 1 in this edition); — MODIFY the “Normative references” (SEE Chapter 2 in this edition); — MODIFY partial contents of the “Terms and definitions” (SEE Sections 3.7, 3.8 and 3.17 in this edition and Sections 3.8, 3.17 and 3.18 in 1998 edition); — RECLASSIFY the products; DELETE the “Disinfection products” and relevant contents (Sections 4.1 and 5.2 in 1998 edition); — MODIFY the requirements for sterile package as “in line with GB/T 19633.1 and relevant standards” (SEE Section 5.2.3 in this edition and Section 5.3.3 in 1998 edition); — Since the categories of corrugated boxes vary from three to two, due to GB 6543 updated in normative references, this Standard has also been modified accordingly (SEE Section 5.3.3 in this edition and Section 5.4.3 in 1998 edition); — ADD the requirements for the information supplied by manufacturer (SEE Chapter 6 in this edition); — The symbols for product package have been partially modified (SEE Section 6.3 in this edition); — DELETE the Chapter 7 “Transport and storage” (Chapter 7 in 1998 edition); — MODIFY the Annex A as “Guidelines for the information of medical devices required to be supplied for meeting the requirements of EU Council Directive 93/42/EEC” (SEE Annex A in this edition and Annex A in 1998 edition); and Medical polymer products - Requirement for package and information supplied by manufacturer 1 Scope This Standard specifies the requirement for package and information supplied by manufacturer of medical polymer products. Note. The provisions of national regulations and product standards take precedence over this Standard. 2 Normative references The following documents are essential to the application of this document. For dated references, only the editions with the dates indicated are applicable to this document. For undated references, only the latest editions (including all the amendments) are applicable to this document. GB/T 3102 (all parts) Quantities and units GB/T 4892 Dimensions of rigid rectangular packages - Transport packages GB/T 6543 Single and double corrugated boxes for transport packages GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times GB/T 19633.1 1 Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements YY/T 0468 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange YY/T 1119 Terminology relating to medical polymer products 1 Being approved. It refers to the legal person or natural person who is expected to accept the information supplied by the manufacturer. 4 Product classification 4.1 When designing the product package, TAKE account of the product’s sanitary requirements first, then the requirements for the package combined with the product’s specific circumstances and physical properties. Therefore, it is necessary to classify the products. 4.2 The products are classified as general products and non-sterile products according to the sanitary requirements. 4.3 According to the physical properties, the products are classified as. — Class A. extrusion resistant products; — Class B. the products whose quality will be affected after extrusion; — Class C. the products whose quality will be severely affected after extrusion; — Class D. the particles, liquid or ointment material or products soaked in preservative solution. Note. The products are classified in accordance with the physical properties for easy reference in the product standards. Specific products can be determined depending on their structure, size, value and safety. 5 Package requirements 5.1 General requirements 5.1.1 The product packages shall be applicable to the storage and transport processes. Ensure that the product quality is not affected during normal storage and transport. Note. The test methods for some transport packages are specified in GB/T 4857. 5.1.2 The primary package materials of the product shall be non-toxic to human bodies, and shall not react with the contents and thus affect the quality of the product and package, thereby ensuring the safety and effectiveness of the use of the contents. 5.1.3 The product package shall be convenient for the use of the product. be added if necessary. 6 Requirements for the information supplied by the manufacturer 6.1 Product identification information 6.1.1 Product category When the category of medical devices belonging to the product needs to be explained in the information supplied, priority shall be given to the denomination in YY/T 0468. 6.1.2 Product denomination The products shall give priority to the names specified in relevant standards and the terminology specified in YY/T 1119. 6.1.3 Batch code The product’s batch code shall be composed of letters and / or figures. However, it can also be expressed in other ways, for instance, using a machine-readable code. 6.2 Product service information 6.2.1 General requirements Any way of supplying information with the product shall take account of the prospective users, service conditions, the safety and effectiveness of the use of single device, etc. The appropriate ways of supplying information shall be based on the risk assessment, and shall be consistent with the training, experience and degree of education of prospective users. Note. The information supplied is required to conform to the requirements of EN 1041 in some international standards for medical devices. The guidelines for the information required to be supplied for meeting the requirements of EU Council Directive 93/42/EEC given in EN 1041 are given in Annex A. For the medical devices using these international standards, the guidelines supplied in Annex A are mandatory. 6.2.2 Special requirements 6.2.2.1 Applicability The dates shall be expressed in the format of YYYY-MM-DD, YYYY-MM or YYYY given in GB/T 7408. The units of measurement shall use the units of international system of measurement or other legal units of measurement specified in GB/T 3102. The symbols and the safety-related identification colors shall conform to the requirements of YY/T 0466.1 and relevant standards. If they are not derived from relevant standards, an indication shall be given in the information supplied. 6.2.2.7 Changes in information supplied For any changes in the information that has been supplied for the user, PASS on the changes clearly to the user if it is important for patient safety. 6.3 Symbols on the product packages 6.3.1 Unit package or primary package The following symbols shall be generally marked on the unit packages or primary packages. a) product name, model or specifications; b) manufacturer’s name, address and trademark; c) manufacturing date, in case of no information on the service life; d) batch code; and e) where appropriate, the word “NON-STERILE” 2. The following symbols shall also be marked on the unit packages or primary packages for non-sterile products. a) the word “STERILE”; b) the words “do not use the damaged package”; c) the words “for single use”; and d) service life. Note. The symbols specified in YY/T 0466.1 may be used to conform to the requirements above. 6.3.2 Symbols on the shelf packages The following symbols shall be generally marked on the shelf packages. a) product name, model or specifications; b) manufacturer’s name, address and trade... ......


YY/T 0313-1998 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA File No.: 2021-1998 Replacing ZB C48006-89 Package, label, transport and storage for medical polymer products ISSUED ON: AUGUST 27, 1998 IMPLEMENTED ON: OCTOBER 01, 1998 Issued by: China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Definitions ... 4  4 Product classification ... 6  5 Package requirements ... 7  6 Label ... 10  7 Transport and storage ... 12  Annex A (Indicative) Requirements for packaging materials and shaped containers for sterilized products after packaging ... 13  Annex B (Indicative) Symbols used on medical device labels, signs and information provided ... 16  Package, label, transport and storage for medical polymer products 1 Scope This Standard specifies the package, label, transport and storage for medical polymer products. This Standard is applicable to the package, label, transport and storage for medical polymer products (hereinafter referred to as the products). Special products are regulated by product standards. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191-90, Packaging and storage marks GB 4892-85, Dimensions of rigid rectangular packages - Transport packages GB 6543-86, Single and double corrugated boxes for transport packages 3 Definitions For the purposes of this document, the following definitions apply. 3.1 contents a generic term for product(s), divider(s), instructions and / or inner package and other articles in a package 3.2 primary package the package in direct contact with the product 3.3 unit package the package for a single product, a set of components related to the operational processes, or a series of products supplied by complete sets, which is the basic a layer of sealed package is supplemented outside the sealed package, which can be structurally unsealed in layers 3.14 single-service package the package in which the quantity of the contents (such as liquid, particles, etc.) is for single use only 3.15 multi-service package the package in which the quantity of the contents (such as liquid, particles, etc.) can be consumed for multiple times 3.16 convenient-for-use package the package with a certain auxiliary function for the clinical use of material contents (for instance, a syringe containing sodium hyaluronate) NOTE 1: The convenient-for-use package is mostly used for Class IV products and shall be regarded as an integral part of the product. 3.17 disinfected products products with an inactivation index of 103 3.18 sterilized products products with an inactivation index of 106 4 Product classification When designing the product package, take account of the product’s sanitary requirements first, then the requirements for the package combined with the product’s specific circumstances and physical properties. Therefore, it is necessary to classify the products. 4.1 The products are classified as general products, disinfected products and sterilized products according to the sanitary requirements. 4.2 According to the physical properties, the products are classified as: - Class I: extrusion resistant products; - Class II: the products whose quality will be affected after extrusion; - Class III: the products whose quality will be severely affected after extrusion; - Class IV: the products that the particles, liquid or ointment material are b) Not easy to break; c) Easy to unpack; d) Once unpacked, it can no longer be sealed, or left a trace of being unpacked; e) When needed, it shall be beneficial to the sterilization process selected by the contents. NOTE 3: The requirements for packaging materials and shaped containers for post-packaging sterilization of products are given in Annex A. 5.3.4 For sterile supply of powder, liquid or ointment materials, single-service package must be used. If the single-service package cannot be used as a sterile package unit, a single layer of unit package shall be added as a sterile package. 5.3.5 Documents such as instructions for use of the product (except for labels that must be attached to the product such as blood bags, blood collection containers, etc.) shall be outside the sterile package. 5.3.6 Sterile products that are not sterilized after packaging, the primary package shall be sterilized first. And use sterile operation technology packaging. 5.3.7 There shall be a sealed package or a clean package on the outside of the sterile package (add a layer directly to unit package or it can be multi-unit package). NOTE 4: Carton shipping packaging cannot be used as a sealed package and clean package. 5.3.8 If only the internal sterility of the product is required, it shall be clearly indicated on the packaging of the product. 5.3.9 If the product is sterilized after completion of the multi-unit package and/or transport package, the multi-unit package and/or transport package shall also be adapted to the selected sterilization process. 5.4 Class I products 5.4.1 Class I products shall have at least minimum package and transport package. 5.4.2 If the contents are required to be kept clean before use, the minimum package shall be sealed package. 5.4.3 The outer package shall adopt the class 2 or 3 corrugated boxes specified in GB 6543. Or a container of other materials with a quality of not less than class 3 corrugated box can be used. package. 5.7.2 The primary package shall prefer to use convenient-for-use package design. 5.7.3 Products that are supplied from a variety of materials and are packaged in single-service package shall be placed in the same unit package. 5.7.4 For products that are packaged in multi-service package, the package shall be strong and durable. Keep closed enough after closing to ensure the effectiveness of the product after the product has been unsealed for a given period of time. 5.7.5 The outer package shall adopt class 1 or 2 corrugated box specified in GB 6543. Or packaging containers of other materials with a quality of not less than class 2 corrugated box. 5.7.6 Class IV disinfected products shall also comply with the provisions of 5.2. 5.7.7 Class IV sterilized products shall also comply with the provisions of 5.3. 5.8 Other considerations 5.8.1 For parts and raw materials that are produced or cleaned in a clean environment and supplied to other manufacturers, the minimum package shall use double-wall package (see 3.13). 5.8.2 For products that affect their quality due to moisture, the package shall be considered as moisture-proof, and if necessary, a moisture-absorbing agent can be added. 6 Label 6.1 General requirements 6.1.1 The label on the package shall correctly guide the transport, storage, unpacking and use of the product. 6.1.2 The label on the package shall be obvious, clear and strong. It shall not fall off or be obscured by the sterilization (if any) used, transport and storage processes. 6.1.3 The label on the primary package shall be printed on the outer surface. Consideration shall be given to the possibility of ink migration into the interior of the package affecting the quality of the contents. 6.2 Unit package or primary package Annex A (Indicative) Requirements for packaging materials and shaped containers for sterilized products after packaging A.1 General requirements NOTE: The purpose of sterilization after packaging of the product is to keep the product sterile when used in accordance with transport and storage conditions. A.1.1 The raw materials used to produce packaging materials can be pure materials or recycled materials. The source and processing history of raw materials, especially recycled materials, shall be well understood and controlled to ensure that the final packaging meets the requirements. NOTE: Sterile package is best not to use recycle materials, otherwise the production waste shall be strictly controlled. A.1.2 Packaging design and processing require the review of selected materials, including effects on the sterilization process. A.1.3 Appropriate test method shall be used for the evaluation of the properties of the material: a) microbial resistance; b) toxicity; c) physical and chemical properties; d) adaptability of materials used and sterilization process; e) adaptability to the shape-forming and sealing process; f) period of storage before and after sterilization of packaging materials. A.2 General performance requirements for packaging materials Packaging materials (such as coils, paper, plastic film or non-woven high- density polyethylene) shall meet the following requirements: a) the material shall be free of extractables, non-toxic and tasteless, stable in physical properties and safety, and not adversely affecting the installed medical devices; ......

Similar standards: YY/T 0316-2016  YY/T 0688.1-2023  YY/T 0841-2023  
Similar PDFs (Auto-delivered in 9 seconds): YY/T 0313-2014  YY/T 0313-1998  YY/T 0454-2008  YY/T 0149-2006