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YY/T 0871-2013

Chinese Standard: 'YY/T 0871-2013'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0871-2013English159 Add to Cart Days<=3 Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses Valid YY/T 0871-2013
YY/T 0871-2013Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY/T 0871-2013; YY/T0871-2013
Description (Translated English): Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 9,976
Quoted Standard: ISO 14534
Adopted Standard: ISO/TS 19979-2004, IDT
Drafting Organization: State Food and Drug Administration, Hangzhou Medical Device Quality Supervision and Inspection Center
Administrative Organization: National Medical optics and instruments Standardization Technical Committee
Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the soft and rigid gas permeable. This standard does not address the following questions: contact lens label national norms.


YY/T 0871-2013
Ophthalmic optics.Contact lenses.Hygienic management of multipatient use trial contact lenses
ICS 11.040.70
C40
People's Republic of China pharmaceutical industry standards
Ophthalmic optics Contact lenses
More patients try contact lenses sanitization
(ISO /T S19979.2004, IDT)
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is identical with ISO /T S19979.2004 "Ophthalmic optics - Contact lenses and more patients try contact lenses Hygiene treatment" (English
Chinese Version).
Correspondence between the consistency of the standards of international documents and normative references of the following documents.
YY 0719.2-2009 optics contact lens care products - Part 2. Basic requirements (ISO 14534.2002, MOD)
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
Mortem hospital.
The main drafters of this standard. Chen Jingyun, Ma Li, Yu Haiying, Zheng, Wen Yan, Li Jiazhong, Zhu Meiqin.
Ophthalmic optics Contact lenses
More patients try contact lenses sanitization
1 Scope
This standard provides guidelines for contact lens manufacturer to manufacturer, and provide relevant information to write an eye care professional for more patients
Who tried soft and rigid gas permeable (RGP) contact lenses sanitary treatment.
Examples tag information can be found in Appendix A.
This standard does not address the following issues.
--- Contact lens label with national norms;
--- In the absence of a contact lens case reports spread of prions, there is no mention of the inactivation of prions.
2 Normative references
The following documents for the application of this document is essential. For cited documents with dates, only the dated edition applies to this document.
For undated references, the latest edition (including any amendments) applies to this document.
ISO 14534 contact lens care products, ophthalmic optics basic requirements (Ophthalmicoptics-Contactlensesand
Contactlenscareproducts-Fundamentalrequirements)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Tried contact lenses trialcontactlens
Diagnostic contact lens diagnosticcontactlens
Professionals from the contact lens fitting or fitting divisions used for selecting the appropriate parameters for the contact lens wearer.
3.2
More patients try contact lenses multipatientusetrialcontactlens
Is more than one contact lens patients try them.
More than four patients tried contact lenses sanitization method
4.1 Overview
Multi-patient contact lens manufacturer tried contact lenses sanitization instructions shall ensure that no heat or chemical treatment methods affect performance
index. Contact lenses and contact lens care products manufacturers should take into account when processing the specified health care system for multi-patient tried contact lenses
It may cause problems (such as. specific contact lenses, contact lens care system incompatibility, chemical composition and/or storage container between).
4.2 single-use conditions
If you are determined to be infectious diseases [eg. Creutzfeldt-Jakob disease (CJD), herpes simplex virus, hepatitis virus, HIV or adenovirus] Potential
Related standard:   YY/T 0872-2013  YY/T 0719.8-2019
Related PDF sample:   YY/T 0864-2011  YY/T 0619-2017
   
 
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