YY/T 1157-2009Activated partial thromboplastin time reagent (kit) (English PDF)
活化部分凝血活酶时间检测试剂（盒）
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1157-2009 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 1157-2009 is the English-translated version of 活化部分凝血活酶时间检测试剂（盒）.
YY/T 1157-2009 is the recommended Chinese medical device and pharmaceutical industry standard for activated partial thromboplastin time reagents and kits.
It gathers the common technical requirements for their quality inspection and testing, with terms and definitions, test methods, marking, labelling and instructions for use, packaging, transport and storage.
The products covered are the APTT reagents used in routine clinical laboratory testing. Reagents intended for bedside point-of-care testing are left outside its scope.
GB/T 191, GB 6682 and YY 0466 are cited. Issued on 30 December 2009, it has applied since 1 June 2011.
Found what you need?
Document preview — YY/T 1157-2009
National Standard of the People's Republic of China
- ICS
- 11.100
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 1157-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 191
GB 6682
YY 0466
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1157-2009
- 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 191-2025 — Graphical symbols marking for handling and storage of packages
YY 0466-2003 — Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 1157-2009
$105.00