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YY/T 0616.2-2016: Medical glove for single use--Part 2: Requirements and testing for shelf life determination
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0616.2-2016 | English | 279 |
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Medical glove for single use--Part 2: Requirements and testing for shelf life determination
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YY/T 0616.2-2016
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Basic data | Standard ID | YY/T 0616.2-2016 (YY/T0616.2-2016) | | Description (Translated English) | Medical glove for single use--Part 2: Requirements and testing for shelf life determination | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 14,198 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 19633.1; GB/T 19633.2 | | Adopted Standard | EN 455-4-2009, NEQ | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements for disposable gloves shelf life. It also specifies the requirements for labeling and disclosure of information relating to the test method used. This standard applies to existing, new and designed products with significant changes. Existing designs that do not have available aging data should produce data within a reasonable period of time. This standard does not specify the bulk size. Need to pay attention to the bulk of the difficulties in circulation and control. The maximum number of recommended production lots is 500 000. | YY/T 0616.2-2016: Medical glove for single use--Part 2: Requirements and testing for shelf life determination
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Medical glove for single use - Part 2. Requirements and testing for shelf life determination
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Disposable medical gloves
Part 2. Requirements and tests for the determination of shelf life
Medicalgloveforsingleuse-Part 2. Requirementsandtestingfor
shelflifed resolution
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
YY/T 0616 "One-time use of medical gloves" is divided into two parts.
- Part 1. Biology evaluation requirements and testing;
- Part 2. Requirements and tests for determining shelf life.
This part is part 2 of YY/T 0616.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section refers to EN455-4..2009 "Disposable medical gloves Part 4. Requirements and tests for determining shelf life".
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part of the drafting unit. Shandong Province, medical equipment product quality inspection center, Shandong Kang Li Medical Equipment Technology Co., Ltd., Shandong Hang Shun
Detection Technology Development Center.
This part of the main drafters. Sun Haipeng, Zhang Peng, Bai Bing, Han Chao.
Introduction
Medical gloves are expected to be used as a barrier to infection. To ensure its effectiveness, the gloves are necessary for hand, impermeable and adequate
Of the physical strength, so that it does not occur in the use of failure. The national standard for medical gloves 1) gives these requirements.
This standard requires manufacturers to conduct stability tests prior to product launch to estimate the shelf life of any new or technically improved gloves
Life, and at the same time the actual time stability study. The actual time stability test can be seen as requiring the manufacturer to supervise the post-market product
The contents of the governor. These requirements are expected to ensure that the manufacturer has sufficient data to support the declaration of the shelf life of its products before listing
Submitted to the regulatory body for review.
1) These standards include GB 7543, GB 10213, GB 24786 and GB 24787 and so on.
Disposable medical gloves
Part 2. Requirements and tests for the determination of shelf life
1 Scope
YY/T 0616 this part of the provisions of the disposable use of gloves shelf life requirements. Also specify the label and the test used
Method related to the disclosure of information requirements.
This section applies to existing, new and designed products with significant changes. It is reasonable to have an existing design that does not have available aging data
Of the time period to produce data.
This section does not specify the bulk size. Need to pay attention to the bulk of the difficulties in circulation and control. The maximum number of recommended production batches
The amount of 500000.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 19633 (all parts) final sterilization of medical equipment packaging
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Arrhenius formula Arrheniusequation
Activation energy (EA), absolute temperature (T) and degradation rate constant [k (T)].
Note. The life of the shelf life of the rubber product is based on the Arrhenius principle of the chemical reaction rate. The Arrhenius formula has the following basic form.
k (T) = A · e
-EA
RT
Where.
A - constant in minutes per minute (min-1);
EA - activation energy in joules per mole (J/mol);
R - General gas constant (8.314J · mol-1 · K-1);
T --- absolute temperature, the unit is Kelvin (K);
k (T) - the rate constant of the degradation process, in minutes per minute (min-1).
Another form of expression of the Arrhenius formula is.
lnk (T) = lnA-
EA
RT ()
The time required for the physical performance to fall below the threshold is inversely proportional to the rate constant k (T).
3.2
Sales package
Is expected to flow to the consumer, with multiple gloves or a pair of gloves packaging.
Note. For example, the initial packaging (peeled packaging) of the sterile product or the dispensing box of the non-sterile product.
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