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YY/T 0313-2014: Medical polymer products - Requirement for package and information supplied by manufacturer Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0313: Historical versions
Similar standardsYY/T 0313-2014: Medical polymer products - Requirement for package and information supplied by manufacturer---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0313-2014 YY PHARMACEUTICAL INDUSTRY STANDARD 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 Table of ContentsForeword... 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... 23ForewordThis 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 — DELETE Annex B (Annex B in 1998 edition). Some of the elements of this document may be the subject of patent rights. The issuing authorities of this document shall not be held responsible for identifying any or all such patent rights. This Standard shall be under the jurisdiction of the National Technical Subcommittee for Standardization of Infusion Sets (SAC/TC 106). Drafting organization of this Standard. Shandong Quality Inspection Center for Medical Devices. Main drafters of this Standard. Wu Ping and Yu Xiaohui. The previous released editions substituted by this Standard are as follows. — ZBC 48006-1989; — YY/T 0313-1998. Medical polymer products - Requirement for package and information supplied by manufacturer1 ScopeThis 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 referencesThe 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 systems3 Terms and definitionsThe terms and definitions defined in GB/T 19633.1 and the following ones are applicable to this document. 3.1 Contents The contents refer to a generic term for product(s), divider(s), instructions and / or inner package and other articles in a package. 3.6 Transport package (outer package) It refers to the packaging unit applicable to product transport. 3.7 Shelf package It refers to the protective packaging unit that is placed on a shelf to ensure that the product meets the intended performance within the service life, in compliance with the manufacturer’s storage conditions. 3.8 Divider It refers to a generic term for the partitions, trays, brackets, cannulas and other protective packaging components that are not mutually extruded among the components with sufficient intensity designed to be a set of products or among the products. 3.12 Sterile package It refers to the package that remains sterile inside. Once it ruptures, no internal sterility is guaranteed. 3.13 Double-wall package A layer of sealed package is supplemented outside the sealed package, which can be structurally unsealed in layers. 3.14 Single-service package It refers to the package in which the quantity of the contents (such as liquid, particles, etc.) is for single use only. 3.15 Multi-service package It refers to the package in which the quantity of the contents (such as liquid, particles, etc.) can be consumed for multiple times.4 Product classification4.1 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.5 Package requirements5.1 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. 5.1.3 The product package shall be convenient for the use of the product. 5.1.4 The size of the rectangular package of the product shall be prioritized with the size specified in GB/T 4892. 5.2.4 For sterile supply of powder, liquid or ointment material, a single-service package shall be used. If the single-service package cannot be used as a sterile package unit, a layer of unit package shall be supplemented as a sterile package. 5.3 Products in Class A 5.3.1 Each product in Class A shall have a minimum package and a shelf package. 5.3.2 If the contents are required to be kept clean before use, a sealed package shall be used as their minimum package. 5.4 Products in Class B 5.4.1 Each product in Class B shall have a minimum package or a unit package and a shelf package. 5.4.2 If the contents are required to be kept clean before use, a sealed package shall be used as their minimum package or unit package. 5.4.3 When the unit package is relatively small, a rigid package shall be used as a multi-unit package. 5.5 Products in Class C 5.5.1 Each product in Class C shall have a minimum package or a unit package, a multi-unit package and / or a shelf package. When the product’s unit package is relatively large, a multi-unit package may not be used. 5.5.2 For a complete set of products consisting of a plurality of separate components, its unit package shall be designed with a divider to prevent mutual extrusion. 5.6 Products in Class D 5.6.1 Each product in Class D shall have at least a primary package (a single-service package or a multi-service package), a multi-unit package and / or a shelf package. When the primary package is relatively large, a multi-unit package may not be used. 5.6.2 The primary package shall be prioritized with the design of the convenient-for-use package. 5.7.1 For the spare parts and raw materials produced or cleaned in a clean environment and provided for other manufacturers, the double-wall packages shall be used as their minimum packages. 5.7.2 For the products whose quality will be affected by moisture, their packages shall be kept away from moisture. Moisture absorption agent shall be added if necessary.6 Requirements for the information supplied by the manufacturer6.1 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. 6.2 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. 6.2.2 Special requirements 6.2.2.1 Applicability The service information shall be applicable to the products in packages. When some products are supplied in multiple forms (such as sterile and non-sterile) or of multiple specifications, information shall be separately supplied for various forms or specifications, respectively. 6.2.2.3 Readability The information expected to be visually recognized shall be readable, taking account of special dimensions and service conditions of particular products for corresponding adjustment, if necessary. 6.2.2.5 Safety As long as it is actually needed, the media for supplying information shall be guaranteed not to be destroyed or deliberately altered by the personnel other than the manufacturer, whether for malicious purposes or not. 6.2.2.6 Normalization The dates shall be expressed in the format of YYYY-MM-DD, YYYY-MM or YYYY given in GB/T 7408. 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 6.3.2 Symbols on the shelf packages The following symbols shall be generally marked on the shelf packages. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
