|
US$369.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 35594-2023: Paper and board for pharmaceutical packaging
Status: Valid GB/T 35594: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 35594-2023 | English | 369 |
Add to Cart
|
4 days [Need to translate]
|
Paper and board for pharmaceutical packaging
| Valid |
GB/T 35594-2023
|
| GB/T 35594-2017 | English | 239 |
Add to Cart
|
3 days [Need to translate]
|
Medical packaging paper
| Obsolete |
GB/T 35594-2017
|
PDF similar to GB/T 35594-2023
Basic data | Standard ID | GB/T 35594-2023 (GB/T35594-2023) | | Description (Translated English) | Paper and board for pharmaceutical packaging | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | Y32 | | Classification of International Standard | 85.060 | | Word Count Estimation | 18,124 | | Date of Issue | 2023-12-28 | | Date of Implementation | 2024-07-01 | | Older Standard (superseded by this standard) | GB/T 35594-2017 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 35594-2023: Paper and board for pharmaceutical packaging---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 85:060
CCSY32
National Standards of People's Republic of China
Replace GB/T 35594-2017
Paper and cardboard for pharmaceutical packaging
Published on 2023-12-28
2024-07-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Foreword
This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents"
Drafting:
This document replaces GB/T 35594-2017 "Medical Packaging Paper": Compared with GB/T 35594-2017, except for structural adjustment and editing
In addition to the modifications, the main technical changes are as follows:
a) Changed the scope (see Chapter 1, Chapter 1 of the:2017 edition);
b) The classification has been changed (see Chapter 4, Chapter 4 of the:2017 edition);
c) Changes in raw material requirements (see Chapter 5, Chapter 5 of the:2017 edition);
d) Change "basic basis" to "quantitative deviation", "tear degree" to "tear index", "burst resistance" to "burst resistance index", "wet resistance"
"Breaking Strength" is changed to "Wet Bursting Index", "Tensile Strength" is changed to "Tensile Index", "Wet Tensile Strength" is changed to "Wet Tensile Index"
"number", and changed the requirements and corresponding test methods (see 6:1:1, 7:2, 7:5, 7:7~7:10, 5:4, 6:2, 6:4,:2017 edition
6:6~6:9);
e) Change the brightness (whiteness) indicator name to D65 brightness, and the fluorescence brightness (whiteness) indicator name to D65 fluorescence brightness:
The name of the chloride content indicator is changed to water-soluble chloride content, and the name of the sulfate content indicator is changed to water-soluble sulfuric acid:
Salt content, changed the D65 brightness, air permeability, water absorption, smoothness, microbial barrier properties technical index requirements (see
6:1:1, 5:3 and 5:4 of the:2017 edition), the test methods for water-soluble chloride content and water-soluble sulfate content have been changed (see 7:12,
7:13, 6:11 and 6:12 of the:2017 edition), the test method for microbial barrier properties has been added (see 7:18);
f) Added technical index requirements for decolorization performance, heavy metal content, and dust level (see 6:1:1) and their test methods (see 7:15, 7:17,
7:20);
g) Added the physical and chemical properties and test methods of cardboard for pharmaceutical packaging (see 6:1:2, 7:17, 7:21~7:24);
h) Added requirements for appearance quality, dimensional deviation and skewness index of paperboard for pharmaceutical packaging (see 6:3 and 6:4:2);
i) Added requirements for microbiological indicators of medical packaging paper and cardboard for pharmaceutical packaging (see 6:2) and their test methods (see 7:25);
j) The inspection rules have been changed (see Chapter 8, Chapter 7 of the:2017 edition);
k) Product identification has been changed (see 9:2 and 9:3, 8:2 and 8:3 of the:2017 version);
l) Added measurement methods for decolorization performance and crease stiffness (see Appendix A and Appendix B):
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
This document is proposed by China Light Industry Federation:
This document is under the jurisdiction of the National Paper Industry Standardization Technical Committee (SAC/TC141):
This document was drafted by: Ningbo Asia Pulp and Paper Co:, Ltd:, Zhejiang Hengda New Materials Co:, Ltd:, Anhui Huabang Gulou New Materials
Co:, Ltd:, Zhejiang Kaifeng New Materials Co:, Ltd:, Xianhe Co:, Ltd:, Asia Pacific Senbo (Shandong) Pulp and Paper Co:, Ltd:, Shandong Jinmai
Material Technology Co:, Ltd:, Huabang Gulou New Materials Co:, Ltd:, China Pulp and Paper Research Institute Co:, Ltd:, Medium and Light Paper Products Inspection and Certification
Ltd:
The main drafters of this document: Wang Xinting, Zhou Xuelin, Yi Fortune, Tang Shengde, Wang Junming, Hu Caiwei, Hu Jiangtao, Liu Xiangbo, Yang Heng, Zhao Xinmin,
Huang Xueying, Ding Pengxiang, Men Junyan, Wang Gang, Yang Jianqing, Yang Gang, Hu Dinggen, Yasuda Tian, Zhang Qi, Wu Minzhe, Yuan Taojing, Feng Yafang, Wen Jianyu,
Liu Yang:
The previous versions of this document and the documents it replaces are as follows:
---First published as GB/T 35594-2017 in:2017;
---This is the first revision:
Paper and cardboard for pharmaceutical packaging
1 Scope
This document stipulates the classification, raw material requirements, technical requirements, inspection rules and markings, packaging, transportation, storage and
Describes the corresponding test methods:
This document applies to the production, inspection and sales of terminally sterilized medical packaging paper and cardboard for pharmaceutical packaging:
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document:
GB/T 450 Collection of paper and cardboard samples and measurement of longitudinal, transverse, front and back sides of the samples
GB/T 451:1 Determination of dimensions and deflection of paper and cardboard
GB/T 451:2 Paper and cardboard Part 2: Quantitative determination
GB/T 454 Determination of paper bursting strength
GB/T 455 Determination of tear strength of paper and cardboard
GB/T 456 Determination of smoothness of paper and cardboard (Buick method)
GB/T 457-2008 Determination of folding resistance of paper and cardboard
GB/T 458-2008 Determination of air permeability of paper and cardboard
GB/T 462 Determination of moisture content of paper, cardboard and pulp analysis samples
GB/T 465:1 Determination of bursting strength of paper and cardboard after immersion in water
GB/T 465:2 Determination of tensile strength of paper and cardboard after immersion in water
GB/T 1540 Determination of water absorption of paper and cardboard - Cobb method
GB/T 1541 Determination of dustiness of paper and cardboard
GB/T 1545-2008 Determination of acidity or alkalinity of aqueous extracts of paper, cardboard and pulp
GB/T 2678:2-2021 Determination of water-soluble chloride in paper, cardboard and pulp
GB/T 2678:6-2023 Determination of water-soluble sulfates in paper, cardboard and pulp
GB/T 2828:1 Enumeration sampling inspection procedures Part 1: Batch-by-batch inspection sampling plan retrieved by acceptance quality limit (AQL)
GB 4789:15-2016 National Food Safety Standard Food Microbiology Test Mold and Yeast Count
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB/T 7974 Determination of blue light diffuse reflection factor D65 brightness of paper, cardboard and pulp (diffuse/vertical method, outdoor daylight conditions)
GB/T 10335:3 Coated paper and cardboard coated white cardboard
GB/T 10335:4 Coated paper and paperboard Coated white paperboard
GB/T 10342 Paper packaging and marking
GB/T 10739 Standard atmospheric conditions for handling and testing of paper, paperboard and pulp samples
GB/T 12914 Determination of tensile strength of paper and paperboard - Constant speed tensile method (20mm/min)
GB 14934 National food safety standard for sterilized tableware (drinking utensils)
GB/T 19633 (all parts) Packaging of terminally sterilized medical devices
GB/T 22364-2018 Determination of bending stiffness of paper and cardboard
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 35594-2023_English be delivered?Answer: Upon your order, we will start to translate GB/T 35594-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB/T 35594-2023_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 35594-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version GB/T 35594-2023?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 35594-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|