YY 1296-2016 PDF English
US$110.00 · In stock · Download in 9 secondsYY 1296-2016: Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 1296-2016 | English | 110 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY 1296-2016
YY 1296-2016: Optics and photonics. Operation microscopes. Light hazard from operation microscopes used in ocular surgery
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY1296-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Optics and photonics - Operation microscopes -
Light hazard from operation microscopes
used in ocular surgery
(ISO 10936-2.2010, Optics and photonics - Operation microscopes - Part 2.
Light hazard from operation microscopes used in ocular surgery, MOD)
Issued on: MARCH 23, 2016
Implemented on: JANUARY 1, 2018
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Light radiation hazard requirements ... 5
5 Test methods ... 6
6 Additional information provided by manufacturer for group 2 instruments .. 7
7 Marks ... 7
Annex A (Informative) Examples of maximum retinal radiation guidance
information provided for operator during operation ... 8
Foreword
All technical content of this Standard is mandatory.
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This Standard is modified on the basis of adopting ISO 10936-2.2010 Optics
and photonics - Operation microscopes - Part 2. Light hazard from operation
microscopes used in ocular surgery.
Compared with ISO 10936-2.2010, the technical differences and reasons in
this Standard are as follows.
On the normative references, this Standard has made the adjustment of
technical differences so as to meet the technical conditions of China. The
adjustment is reflected in Clause 2 "Normative references". It used GB
11239.1-2005 to replace ISO 10936-1 used as reference in ISO
10936-2.2010.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee of National
Technical Committee on Medical optics and instruments of Standardization
Administration of China (SAC/TC 103 / SC 1).
The drafting organization of this Standard. Zhejiang Medical Device Testing
Institute.
Main drafters of this Standard. Wang Jingtao, Jia Xiaohang, He Tao, Peng
Jianhua.
Optics and photonics - Operation microscopes -
Light hazard from operation microscopes
used in ocular surgery
1 Scope
This Standard specifies the basic requirements and test methods for light
hazard from operation microscopes used in ocular surgery.
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 11239.1-2005, Operation microscopes Part 1. Requirements and test
methods (ISO 10936.1.2000, MOD)
ISO 15004-2.2007, Ophthalmic instruments - Fundamental requirements
and test methods - Part 2. Light hazard protection
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 group 1 instrument
the ophthalmic instruments that have no potential light hazard and meet
requirements of 5.2 in ISO 15004-2.2007
NOTE. It is quoted from ISO 15004-2.2007.
3.2 group 2 instrument
the ophthalmic instruments that have potential light hazard and cannot meet
requirements of 5.2 in ISO 15004-2.2007.
NOTE. It is quoted from ISO 15004-2.2007.
6 Additional information provided by manufacturer
for group 2 instruments
6.1 Continuous wave light source with strong variable light intensity shall be
indicated in the instructions for use. When the instrument is set at the
maximum value and 50% of the maximum value, with or without retinal
protection device, it shall meet the time required by the maximum exposure
guidance value specified in 6.5.1 of ISO 15004-2.2007 (see Clause 7 of ISO
15004-2.2007).
During the operation, such information shall be obvious to operator (see
Clause 7 of ISO 15004-2.2007). Annex A gives the example for how to
provide such information.
6.2 If applicable, the pulsed light source with strong variable light shall be
indicated in the instructions for use. When the instrument is set at the
maximum value and 50% of the maximum value, with or without retinal
protection device, it shall meet the number of pulses required by the
maximum exposure guidance value specified in 6.5.1 of ISO 15004-2.2007.
7 Marks
The marks for operation microscopes shall be in accordance with the
provisions of GB 11239.1-2005.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY 1296-2016 be delivered?Answer: The full copy PDF of English version of YY 1296-2016 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY 1296-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY 1296-2016_English will be deemed to be sold to your employer/organization who actually paid 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. www.ChineseStandard.us -- YY 1296-2016 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. How to buy and download a true PDF of English version of YY 1296-2016?A step-by-step guide to download PDF of YY 1296-2016_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY 1296-2016".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |