YY/T 0313-2014Medical polymer products—Requirement for package and information supplied by manufacturer (English PDF)

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.

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.

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.

5.3 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.

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.

6.2 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. […]