Some standard content:
Pharmaceutical Industry Standard of the People's Republic of China
YY 0336—2002
Sterile yagina dilator for single use2002-04-24 Issued
State Drug Administration
2002-10-01 Implementation
YY0336·2002
In order to increase the volume of sterile vaginal dilators for single use, ensure the safety and reliability of clinical use, and protect the health of patients, based on the requirements of the People's Republic of China and the National Drug Administration, the industry standard for sterile vaginal dilators for single use is specially formulated. Sterile vaginal dilators for single use are medical devices for obstetrics and gynecology examinations, and their quality directly affects people's safety and health. For this reason, the standard is issued as a mandatory standard. This standard is proposed by the National Standardization Technical Committee of the Ministry of Health. The drafting unit of this standard is: Yuhuan County Xingkang Pharmaceutical Research Institute, the main drafter of this standard is: Lin Jing.
This standard is approved by the National Standardization Technical Committee of the People's Republic of China for the quality of education equipment.
Pharmaceutical Industry Standard of the People's Republic of China
Sterile yagina dllator for yingle useYY Q33620G2
The standard specifies the following changes and notes on the classification and name of the products of the purchaser, requirements, test methods, test rules, tables, instructions and other installation, pollution, and effectiveness requirements. The standard is applicable to the expanded account. This product is for obstetrics and gynecology examination. 2 Reference standards
The provisions contained in the following standards need to be used in this small and medium-sized application to constitute the provisions of this standard. This standard is used in a small and medium-sized application. The version shown in this standard is slightly different. All standards will be revised. All parties using this standard will explore the possibility of using the latest version of the following standards. (111-2900 package Packing storage delivery icon mark
CBT2X28—！ ！ 37 batch by batch counting sample forced stop and extraction table (near - ten consecutive strong grid check) solid period should be sold count rate sequence and closing table through the monthly production stability inspection) GB/T2829138Y
9.1-1995 industry product use manual said listening book general rules G1/T14233.1-1998 medical monkey blood, injection device only sign the first part: chemical analysis method (G1314233.2-1993 medical blood. Finger technique, injection device filling method two shadow analysis: biological test method G5/ 1.I416193
【Product Detailed Description General Principles for Delivery of Medical Products
Biological Evaluation Test for Silicone Materials G3/T 16175
1686.1201 Biological Evaluation Test for Medical Devices Service Evaluation and Integrity Test YY113-19 Medical Electronic Product Packaging, Labeling, Transportation and Storage 3 3.1 The expander is mainly composed of an upper leaf, a lower leaf and a handle: its structure, specifications and basic dimensions are shown in Table 1 and Table 1. The following are the main specifications and basic dimensions of the expander: The following are the main specifications and basic dimensions of the expander: Table 1 shows the main specifications and basic dimensions of the expander. 3.2 Guidelines and examples: State Drug Administration Approved on April 24, 2002 361 Implementation date: October 1, 2002 YY 03362002
Landau dilatorbzxZ.net
One-time use
According to the inspection model
Figure 1 Disposable non-invasive dilator
YY336-2002
shown, the product contains disposable type, medium length Um, width 2mm: standard: 1YKQ-1xY-200
33 The specification is made of highly toxic plastic. 4 Requirements
4.1 Usability
4.1.1 The size of the dilator can be 1. or. It meets the requirements of 4.1.2 in 3. When the expander is opened, the front outer height and rear outer height are shown in Table 2. Table 2 Specifications of front outer height and rear outer height
Smallest
Front outer height
Largest
10-5
Rear outer height
4.1.3 The surface of the expander should be smooth, the edge should be smooth, without burrs, and there should be no traces of powder or watermarks 4..4 The expander should be adjusted and closed at each time. There should be no signs of looseness 4.1.5 The rotation of the expander shaft pin and shaft hole should be flexible and should not be loose or stuck. 4.1.6 The difference between the upper and lower ends of the expander should not be greater than 2mm. 4.1-7 Each joint and seat should not be stuck 4.1.8 The size of the expander should not be smaller than the standard under any working state. 4.2 Physical properties
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4.3.3.1 Longitudinal cell pressure-reaction is not greater than level 1 4.3.3-2 Sensitization, skin reaction is not complete, 5 1 destruction 4.3.3.3 Irritation, no skin reaction PII is UU~L.15 Test method
5.1 Use 4 energy
5.1.1 Use general or special mother soldiers to see the grass: it should comply with the provisions of 4.[.1, and: it is the width of the head of the upper and lower leaves of the dilator
5.\2 Use general or special to measure the dilator. The front pin port sensitive point height) and the rear port most sensitive point (10,000) should comply with the provisions of 4.1.2
5.1.3 Check the daily plan and hand model. It meets the requirements of 1.1.3 and 4.1.? 5.1.4 Add 20N at 20mm in front of the upper leaf, expand from closed to open, which shall comply with the requirements of 4.1.4 and 4.1.5:
YY 0336-2002
5.1.5 The expander is closed, and the head end is measured with a universal vehicle. The tolerance of the head end shall comply with the requirements of 4.5-1.6 Place the expander in any working position, and observe the force on the bottom of the expander. The result shall comply with the provisions of 1-1.X.
5.2 Physical properties
5.2.1 Requirements: When the expander is raised to the base point below the base, add 20N at 20mm in front of the upper leaf. The load caused by the expander shall be estimated. 5.2.2 Strength: Apply a constant load of 35N in a vertical direction of 1m at a distance of m from the upper belt, which shall meet the requirements of 4.2.2. 5.3 Sterility: The test shall be conducted in accordance with GB/T14233.8-1993. The test shall be conducted in accordance with the method of GB/T11233.21S93 2.4 System Preparation 5.3.2 Ethylene Oxide Retention: Conduct the test in accordance with GB3/T14243.11006. 4.3.2 provisions. 5.3.3 Biological evaluation section
5.3-3.1 Oxygen supply: According to the 4th section of BT16175-1995: Should comply with the provisions of 4-5-3.1: 5.3.3.2 Effect list: According to the method of GB/116175-199e, should comply with the provisions of 1.3.3.2. 6.3.3.3 Stimulation: According to the method of GB/1617-10, should comply with the provisions of 4.3.3.5, 6 Verification and testing
6.1 Tensioner manufacturing factory quality department 6.2 The equipment should be submitted for inspection in batches, which can be divided into standard inspection (standard inspection) and periodic inspection (type inspection). 6.3 The production batches are made of the same materials, process equipment and production conditions. 6.4 Inspection of different batches 6.4.1 The inspection of different batches shall be carried out in accordance with the relevant provisions of G13/T2x. 6.4.? The sampling is the sampling of the second batch. The strictness of the batch sampling plan starts from the normal inspection sampling rate. The non-conforming and non-conforming groups are inspected and the inspection level and qualified quality level AQI are determined.> All the tables are connected. Table of medical batch changes
This meeting's standard score (number of qualified products per unit)
and qualified score
4.1.7,4.-.3.
road west entrance
inspection level
combination quality level
each part is in compliance
4 1 4.4 :.5.
4..7,4. -.X.
4.2.1.4.2.2
Note: The products with environmental protection and ethylene oxide content shall be inspected in the factory 6.5 weeks after the original release (4.32) before the two-stage inspection
6.5.1. From the batch-by-batch inspection, the batch shall be inspected periodically. 6.5.2 Periodic inspections should be conducted in the following cases: (1) before product failure (including product conversion) during continuous production, (2) when there is a major change in production, (3) when there is a shortage or material judgment, and (4) when there is a major change in production. 6.5.3 During the same period, the inspection should be conducted by the inspection and testing machine. (6.5.4 Weekly inspection results should be conducted using the oil sample plan, qualified classification, material comparison, inspection items, underwater judgment, unqualified quality acceptance (RQL) and sample plan table 4. 6.5.5 Under the following conditions, the seat is safe K/1168-0U+3.? 4..3 can be exempted under the following circumstances: The final product shall undergo a new scientific evaluation (when the materials or technical components used in manufacturing the product are changed:) The product formula, process or packaging components are changed! Any changes in the product during the storage period
d) Product monthly payment:
e If there are any changes, it is found that the product will produce a sound when used on the human body.
Unqualified categories:
7 Markings, instructions for use
7. 1 Marking
7.1.1 Single-packaging marking
4. t. 2, 1. 1. 3.
. 1. 1.1. 1. 5.
t.3.1,4.3. 2.
. 1.7.1.1.8
1- 2. 1.1- 2. 2
m—x_a.1]
The markings on the packaging of the expander should be clear and should include the following: 1) Product name, specification:
b! Product standard number, product registration number:
) Manufacturer name and trademark:
u) Production number or date:
— 10 -2]
There should be "youji" in detail/without grape shape symbol, "use for sale", "other fakes are all collected from the company\school, 1) Expiration date,
7.1.24 The label
on the middle packaging of the expander should be clear and should include the following: 2) Product name and specification:
h) Product label, product certification number:
c\ Product certificate,
d) Manufacturing unit name, location and label:
) Production batch number or expiration date:
7. 1.3 Outer packaging markings 7.1.3.1 The outer packaging markings shall include the following: a) product name and specifications; b) manufacturer’s service level and address:
) production batch number or date; d) production approval number:
e) “一活件，H\” or other characters or symbols:
g) product quantity
h) effective date:
) area (length × width × height)
YY 0336
7.3.2 The outer packaging box shall be marked with GB1! logo, other general notes and symbols such as “Pressure with care”, “Filter”, “Fireproof”, “Pressure”, etc.
7.2 Instruction sheet
The instructions for use of the expander shall comply with the relevant provisions of 15996S.1·-1998. 8 Packaging, transportation, storage
8.1.1 Small packaging: single expander 8.1.2 Medium packaging: each small single packaging. One material package (or one box! 1.3 Large packaging: The outer packaging of the expander should be firm and take necessary measures. The large package should contain the product certificate.
81.4 The other contents of the product certificate code should comply with the relevant provisions of CB 14436-1S93. 82 Transportation, some of which shall comply with Y/G313-1998 Section 7: 8.3 The expander shall be valid for 2 years under the conditions of storage. G1 Small package: single expander. 8.1.2 Medium package: each small single package. One material package (or one box! 1.3 Large package: the outer packaging of the expander should be firm, and the large package should be filled with the product certificate. 81.4 The other contents of the product certificate should comply with the relevant provisions of CB 14436-1S93. 82 Operation cycle, some virtual compliance with Y/G313-1998 Section 7: 8.3 The expander can meet the current conditions, the validity period of the bacterium should be 2 years.1 Small package: single expander. 8.1.2 Medium package: each small single package. One material package (or one box! 1.3 Large package: the outer packaging of the expander should be firm, and the large package should be filled with the product certificate. 81.4 The other contents of the product certificate should comply with the relevant provisions of CB 14436-1S93. 82 Operation cycle, some virtual compliance with Y/G313-1998 Section 7: 8.3 The expander shall be valid for 2 years under the conditions specified in the storage.
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