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YY/T 0313-2014: Medical polymer products - Requirement for package and information supplied by manufacturer
YY/T 0313-2014
Medical polymer products.Requirement for package and information supplied by manufacturer
ICS 11.080.040
C30
People 's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0313-1998
Medical polymer products
Packaging and manufacturer's request for information
Released on.2014-06-17
2015-07-01 implementation
State Food and Drug Administration issued
Preface
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0313-1998 "Packaging, marking, transportation and storage of medical macromolecules". And YY/T 0313-1998
Compared to the main changes are as follows.
--- modified the standard name;
- modified the standard for "scope" (see Chapter 1);
- modified the "normative reference document" (see Chapter 2);
- modified part of the terms "terms and definitions" (see 7.3, 3.8, 3.17,.1998 3.8, 3.17, 3.18);
- reclassification of products, cancellation of "disinfection products" and related content (1998 edition 4.1,5.2);
- Amend the requirements for aseptic packaging to meet GB/T 19633.1 and related standards (see 5.3.2,.1998 5.3.3);
--- As a result of normative reference documents GB 6543 update, corrugated box classification from three categories into two categories, the standard also made the corresponding
Modified (see 5.3.3,.1998 edition 5.4.3);
- increased the requirement to provide information to the manufacturer (see Chapter 6);
- a partial modification of the product packaging mark (see 6.3);
- delete Chapter 7, "Transport and Storage" (Chapter 7 of.1998);
- Appendix A is amended to read as follows. "Guidelines for the provision of information required by medical devices to meet European Directive 93/42/EEC" (see Appendix A,
1998 Appendix A);
- Delete Appendix B (Appendix B of the.1998 edition).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard by the National Standardization Technical Committee of infusion equipment (SAC/TC106) centralized.
This standard drafting unit. Shandong Province medical equipment product quality inspection center.
The main drafters of this standard. Wu Ping, Yu Xiaohui.
This standard replaced the previous version of the standard release.
--- ZBC48006-1989;
--- YY/T 0313-1998.
Medical polymer products
Packaging and manufacturer's request for information
1 Scope
This standard specifies the requirements for the packaging of medical polymer products and the information provided by the manufacturer.
Note. National regulations and product standards in the provisions of priority over this standard.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 3102 (all parts) quantities and units
GB/T 4892 hard square transport package size series
Single Corrugated Box and Double Corrugated Box for Transport Packaging
GB/T 7408 Data element and exchange format Information exchange date and time representation
GB/T 19633.11) Final sterilization of medical device packaging - Part 1. Requirements for materials, sterile barrier systems and packaging systems
1) Approval.
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
YY/T 0468 Designation of medical device naming systems for managing data exchange
YY/T 1119 Medical polymer product terminology
3 terms and definitions
GB/T 19633.1 Definitions and the following terms and definitions apply to this document.
3.1
Contents of contents
Packing products, partitions, instructions and/or internal packaging and other items in general.
3.2
Initial package primarypackage
Direct contact with the product packaging.
3.3
Single package unitpackage
Single piece of product, a set of operational processes related to the components or complete sets of products supplied by the packaging. Is the product sales, the use of the basic
unit.
3.4
Small package
The smallest unit of product packaging.
3.5
In the packaging multi-unitpackage
A number of single packaging, small packaging (no single packaging), a single amount of packaging or multi-dose packaging of the protective packaging unit.
3.6
Transport packaging (outer packaging) transportpackage (outerpackage)
Suitable for the transport of goods packaging unit.
3.7
Shelf packaging
In compliance with the manufacturer's storage conditions, placed on the shelf to ensure that the product within the period of use to meet the expected performance of protective packaging
unit.
Note. According to the circumstances in the packaging or transport packaging (packaging) can be shelf packaging.
3.8
Divider divider
There is sufficient strength, designed into a set of products between the various components or between the products are not squeezed between the compartment, tray, bracket, casing and other security
Conservative packaging components of the general term.
3.9
Hard packaging rigidpackage
After the contents are loaded or removed, the container shape does not change substantially. The container is generally made of cardboard, hard plastic, glass, gold
And other materials made of.
3.10
Sealed package
Can guarantee that the contents of the packaging is not easy to contaminated. Once damaged, can not guarantee internal cleaning.
3.11
Cleaning package cleanpackage
To ensure that the contents of the packaging without pollution. Such as cartons, plastic boxes, unsealed plastic bags and so on.
3.12
Sterile packaging sterilepackage
Insistically remain sterile inside. Once damaged, can not guarantee the internal aseptic.
3.13
Double wrapping double-walpackage
In the sealed package plus a layer of sealed packaging. The structure can be layered open.
3.14
One-time package single-service package
The amount of the contents (such as liquids, granules, etc.) is only for one use.
3.15
Multi-service packaging multi-service package
The contents of the contents (such as liquids, granules, etc.) can be consumed a number of times.
3.16
It is packed with convenient-for-usepackage
For the clinical use of the contents of the packaging has a certain function (such as sodium hyaluronate with a syringe).
Note. The use of packaging for D products, should be regarded as an integral part of the product.
3.17
User user
Any legal person or natural person who is expected to accept the information provided by the manufacturer.
4 product classification
4.1 in the design of product packaging, we must first consider the health requirements of products, and then combined with the specific circumstances of the product and the physical nature of the package
Equipment requirements, so it is necessary to classify the product.
4.2 products according to health requirements are divided into ordinary products and sterile products.
4.3 products according to the physical nature is divided into.
--- Class A. resistant to extrusion products;
- Class B. products subject to extrusion to a certain impact on their quality;
- Class C. products subject to severe crushing of their quality;
- Class D. granules, liquids or ointment materials or products immersed in a maintenance solution.
Note. according to the physical properties of the product classification, is to facilitate the product standard reference. Specific products depending on their structure, size, value and safety and so on
to make sure.
5 Packaging requirements
5.1 General requirements
5.1.1 The packaging of the product shall be applicable to the storage and transportation process. Should ensure that the product quality in the normal storage, transportation process without damage.
Note. GB/T 4857 specifies the test method for part of the transport package.
5.1.2 The initial packaging of the product should be non-toxic to the human body, should not react with the contents of the product and the impact of the quality of packaging
The safety and effectiveness of the use of the contents.
5.1.3 The packaging of the product should be convenient for the use of the product.
5.1.4 The rectangular packaging size of the product should be given the size specified by GB/T 4892.
Note. the packaging of other requirements, according to the agreement between supply and demand to set.
5.2 aseptic products
5.2.1 The largest unit of aseptic packaging for sterile products should be single pack.
5.2.2 For products supplied from sterile and non-sterile components, the aseptic packaging unit may be a small
package.
5.2.3 Aseptic Packing Unit shall comply with the requirements of GB/T 19633.1.
Note. YY/T 0698 specifies the requirements for the final sterilization of medical equipment packaging materials, YY/T 0681 provides a sterile medical device packaging test method requirements.
These standards may be used in part to demonstrate that the package complies with the requirements of GB/T 19633.1.
5.2.4 For sterile supply of powder, liquid or ointment material, should be used in a single amount of packaging. If the amount of packaging can not be used as a nonexistent
The bacteria packaging unit should be supplemented with a layer of single pack as a sterile package.
5.2.5 product manual and other documents (blood bags, blood collection containers, etc. should be attached to the label on the product) should be in the aseptic packaging.
5.2.6 Sterile products that are no longer sterilized after packaging shall be sterilized first and sterilized by sterile operation.
5.2.7 Aseptic packaging should be a layer of sealed packaging or cleaning packaging (can be directly in a single package plus a layer, it can be in the packaging).
Note. carton shipping packaging can not be used as a sealed package and a clean package.
5.2.8 If only the product is required to be sterile (eg sterile liquid), it shall be clearly indicated on the packaging of the product.
5.2.9 If the product is sterilized after completion of the packaging and/or transport packaging, the packaging and/or shipping package shall also be adapted to the
Select the sterilization process.
5.3 Class A products
5.3.1 Class A products should be at least as small as packaging and shelf packaging.
5.3.2 If the contents of the required to keep clean before use, the small package should be sealed packaging.
5.3.3 shelf packaging at the same time as a transport packaging, should be used GB/T 6543 provisions of Category 1 or 2 corrugated boxes, or the use of quality is not
Lower than 2 types of corrugated boxes of other materials containers.
5.3.4 Sterile Class A products shall also comply with 5.2.
5.4 Class B products
5.4.1 Class B products should be at least a small package or a single package and shelf packaging.
5.4.2 If the contents are required to be kept clean before use, their small package or single package should be sealed.
5.4.3 single package is small, the packaging should adopt hard packaging.
5.4.4 shelf packaging at the same time as a transport packaging, should be used GB/T 6543 provisions of Category 1 or 2 corrugated boxes, or the use of quality is not
Lower than 2 types of corrugated boxes of other materials packaging containers.
5.4.5 Sterile Class B products shall also comply with 5.2.
5.5 Class C products
5.5.1 Class C products shall be of at least a small package or a single package, medium package and/or shelf packaging. When the product package is large, it can not
package.
5.5.2 A set of products consisting of a plurality of separate components, which are designed to be designed to prevent mutual compression.
5.5.3 There is no partition in a single package, the single package should be hard packaging, otherwise, between the single package should have partitions to prevent mutual extrusion.
5.5.4 shelf packaging at the same time as a transport packaging, should be used GB/T 6543 provisions of Category 1 or 2 corrugated boxes, or the use of quality is not
Lower than 2 types of corrugated boxes of other materials packaging containers.
5.5.5 Sterile Class C products shall also comply with 5.2.
5.6 Class D products
5.6.1 Class D products should be at least an initial package (one pack or multiple packs), medium package and/or shelf packaging. Original packaging
Larger, it can not be packed.
5.6.2 The initial packaging should be preferred to use the packaging design.
5.6.3 Products supplied by a combination of multiple materials and packaged in a single dosage shall be loaded into the same single package.
5.6.4 The use of multiple packaging products, the packaging should be strong, durable, closed after the closed, enough to ensure that after the product is opened in the manufacture
The validity of the use within the given period of the plant.
5.6.5 shelf packaging at the same time as a transport packaging, should be used GB/T 6543 provisions of Category 1 or 2 corrugated boxes, or the use of quality is not
Lower than 2 types of corrugated boxes of other materials packaging containers.
5.6.6 sterile D products should also comply with the provisions of 5.2.
5.7 Other considerations
5.7.1 production or cleaning in a clean environment, to other manufacturers of spare parts and raw materials, small packaging should adopt double packaging.
5.7.2 Due to moisture will affect the quality of its products, the packaging should be considered moisture, if necessary, add moisture agent.
6 manufacturer's request for information
6.1 Product identification information
6.1.1 Product category
When the information provided in the need to explain the product belongs to the medical device category, should be given priority in the YY/T 0468 in the name.
6.1.2 Product naming
The product is preferentially used for the names of the relevant standards and the terms specified in YY/T 1119.
6.1.3 Batch Code
The batch code of the product shall consist of letters and/or numbers, but may also be expressed in other ways, for example using machine readable code....