YY/T 0313-1998 (YY/T 0313-2014 Newer Version) PDF English
YY/T 0313-1998 (YY/T0313-1998, YYT 0313-1998, YYT0313-1998)
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Medical polymer products. Requirement for package and information supplied by manufacturer
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| YY/T 0313-1998 | English | 85 |
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Package, lable, transport and storage for medical polymer products
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Newer version: YY/T 0313-2014 Standards related to (historical): YY/T 0313-2014
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YY/T 0313-1998: PDF in English (YYT 0313-1998) 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;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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