YY/T 1662-2019Quality control material for clinical chemistry analyzer (English PDF)
生化分析仪用质控物
This is a limited preview
Buy now to download the full PDF (22 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1662-2019 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 31, 2019
Implementation date
June 1, 2020
Scope
YY/T 1662-2019 is the English-translated version of 生化分析仪用质控物.
YY/T 1662-2019 is the Chinese pharmaceutical industry standard for the quality control material used on clinical biochemistry analysers, the sample with assigned values and acceptable ranges that a laboratory runs for internal quality control.
It sets the requirements, the test methods, the labels, the instructions for use and the rules for packaging, transport and storage, covering the appearance and the reconstitution where the material is lyophilised, the assigned values and their ranges, the uniformity between vials, the stability of the material both unopened and in use, and the commutability with patient samples. Issued on 31 May 2019, it has applied since 1 June 2020.
Found what you need?
Document preview — YY/T 1662-2019
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements for quality control materials used on biochemical analyzers, including requirements, test methods, labels, instructions for use, Packaging, transportation and storage, etc.
This standard applies to controls for biochemical analyzers with acceptable intervals/values intended for laboratory internal quality control purposes.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Reference material
One or more specified characteristics are sufficiently uniform and stable to have been proven to be suitable for use in measurement or nominal property testing substance. [GB/T 29791.1-2013, definition 3.58]
3.2 Quality control material
Reference material used to measure quality control. [ISO Guide 30..2015, definition 2.22]
4 Requirements
4.1 Traits
The state of the control and the normal appearance requirements, including the matrix, color, etc., should be specified.
4.2 Loading
The net content when the liquid is in the state should be no less than the indicated value.
4.3 Acceptable interval/value
The recommended acceptable interval/value (or inclusion interval) and its determination procedures should be given and should meet the following requirements.
a) acceptable intervals/values should take into account the medical decision level or a suitable concentration point within the measurement interval;
b) acceptable intervals/values shall be given together with the specified measuring system (reagents and instruments);
c) the number of trials, the number of repetitions and the time limit for the evaluation of the acceptable interval/value;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1662-2019
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1662-2019
$150.00