YY/T 0616.1-2016 English PDF (YYT0616.1-2016)

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YY/T 0616.1-2016: Medical gloves for single use--Part 1: Requirements and testing for biological evaluation
YY/T 0616.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
Replacing YY/T 0616.1-2007
Medical gloves for single use - Part 1.
Requirements and testing for biological evaluation
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements... 7
5 Test methods ... 9
Annex A (normative) Method for determining water-soluble proteins of natural
rubber gloves by improved Lowry analytical method ... 11
Annex B (informative) Immunoassay method for natural rubber latex allergens
... 23
Annex C (informative) Determination of amino acids (AAA) by high performance
liquid chromatography (HPLC) ... 28
Bibliography ... 37
Foreword
YY/T 0616 “Medical gloves for single use” consists of the following parts.
- Part 1. Requirements and testing for biological evaluation;
- Part 2. Requirements and testing for shelf life determination.
This Part is Part 1 of YY/T0616.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0616-2007 “Medical gloves for single use -
Requirements and testing for biological evaluation”. Compared with YY/T 0616-
2007, the main technical changes are as follows.
- MODIFY the standard name;
- MODIFY and SUPPLEMENT “3 Terms and definitions”;
- ADD “4.4 Powder, 4.5 Leachable proteins and 4.6 Labeling";
- MODIFY Annex B Immunoassay method for natural rubber latex allergens;
- MODIFY Annex C Determination of amino acids (AAA) by high performance
liquid chromatography (HPLC);
- DELETE Annex D Terms.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The drafting authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Part is under the jurisdiction of China Food and Drug Administration Jinan
Medical Device Quality Supervision and Inspection Center.
Drafting organizations of this Part. Shandong Medical Device Quality Inspection
Center, Beijing Institute of Medical Device Testing, Jiangsu Institute of Medical
Device Testing.
Main drafters of this Part. Hao Shubin, Liu Bin, Liu Xiaoshuai, Huang Yongfu,
Lin Hongsai, Gao Jingxian, Jin Meng.
The historical edition of the standard replaced by this Part is as follows.
- YY/T 0616-2007.
Introduction
In recent years, it is often reported that latex products cause adverse reactions
to medical personnel and patients due to the presence of latex proteins. The
adverse reactions due to residues such as chemicals, lubricants, sterilized
residues (ethylene oxide) and pyrogens are also described in scientific
bibliographies. Among them, the most commonly reported are adverse
reactions caused by natural rubber latex gloves, but gloves made of other
polymers can also cause some adverse reactions.
GB/T 16886 series of standards specifies the requirements and test methods
for biological evaluation of medical devices. However, adverse reactions (such
as immediate hypersensitivity reactions) caused by the use of medical gloves
are not involved. These adverse reactions are mainly caused by the specific
allergens present in the gloves. The factors for these reaction risks are.
a) the time and frequency of skin contact with the gloves;
b) the mucous membranes and the skin (especially when incomplete) are in
direct contact with allergens [Translator note. There is another nick-name
in Chinese] and inhalation particles;
c) how closely the gloves are applied to the skin during use.
FDA believes that the powder in gloves is also a source of danger, which may
lead to foreign body reaction and granuloma formation, and may also lead to
irritant dermatitis, type IV allergy, etc. It may be used as an airborne carrier for
natural latex to cause users allergy.
This Part gives the requirements and test methods for the biological safety
evaluation of medical gloves, which is taken as a part of the risk analysis
process according to YY/T 0316 and GB/T 16886.
Medical gloves for single use - Part 1.
Requirements and testing for biological evaluation
1 Scope
This Part of YY/T 0616 specifies the requirements for the biological safety
evaluation of medical gloves for single use, and gives the requirements for the
labeling and disclosure of information for the test methods used.
This Part applies to the biological safety evaluation of medical gloves for single
use.
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 16886 (all parts) Biological evaluation of medical devices
GB/T 21869 Medical gloves - Determination of removable surface powder
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2008, ISO 14971.2007, IDT)
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 0466.1-2009, ISO 15223-1.2007, IDT)
Pharmacopoeia of the People’s Republic of China (2010 edition)
ISO 7000 Graphical symbols for use on equipment - Index and synopsis
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
chemicals
Substances that are added or formed during or after any process of the
production process. These substances can be detected from the final product.
NOTE. These chemicals include lubricant, chemical coating and sterilant. Chemicals
are often used during glove processing and some of them are known to cause type IV
hypersensitivity. The type, the residual amount and the final form of presence of the
chemicals added are uncertain.
3.2
endotoxins
Lipopolysaccharide that is derived from the of the outer structure of the Gram-
negative bacterial cell membrane.
NOTE. Endotoxin is a pyrogen. Endotoxins may come from the raw material of gloves,
especially the water used in the process of production, and bacteria contamination
caused by manual processing.
3.3
powder
Under this test condition, all water-insoluble substances that can be removed
by washing with water on the glove surface.
[GB/T 21869-2008, definition 3.1]
NOTE. Including intentionally added powder and other processing aids or
unintentionally randomly present substances, these substances can easily be
separated from the surface of gloves. This Part specifies that any glove containing less
than or equal to 2 mg of powder is a powder-free glove, and a glove with more than 2
mg of powder is a powdered glove (see 4.4 for requirements).
3.4
process limit
The possible maximum value of a confirmed process.
3.5
allergenic proteins
Proteins that can cause type I allergic reactions.
3.6
leachable proteins
Water-soluble proteins and peptides with different molecular weights that can
be leached from the final product.
3.7
pyrogens
Substances that make rabbits fever. These substances may also cause the
human body to have a fever reaction and other adverse reactions.
4 Requirements
4.1 General
Medical glov...