YY/T 0313-2014 PDF in English
YY/T 0313-2014 (YY/T0313-2014, YYT 0313-2014, YYT0313-2014)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YY/T 0313-2014 | English | 115 |
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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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Standards related to (historical): YY/T 0313-2014
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YY/T 0313-2014: PDF in English (YYT 0313-2014) 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...
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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