YY/T 0313-2014_English: PDF (YY/T0313-2014)
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Medical polymer products. Requirement for package and information supplied by manufacturer
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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| Word Count Estimation | 14,196 | Date of Issue | 2014/6/17 | Date of Implementation | 2015/7/1 | Older Standard (superseded by this standard) | YY/T 0313-1998 | Quoted Standard | GB/T 3102.1; GB/T 3102.2; GB/T 3102.3; GB/T 3102.4; GB/T 3102.5; GB/T 3102.6; GB/T 3102.7; GB/T 3102.8;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. | 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C48 | Word Count Estimation | 11,165 | Date of Issue | 1998/8/27 | Date of Implementation | 1998/10/1 | Older Standard (superseded by this standard) | ZB C48006-1989 | Quoted Standard | GB 191-1990; GB 4892-1985; GB 6543-1986 | Drafting Organization | State Pharmaceutical Administration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;
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