YY/T 1545-2017Evaluation of connection between haemodialysis concentrate and haemodialysis equipment (English PDF)
血液透析用浓缩物与血液透析设备连接的评价
This is a limited preview
Buy now to download the full PDF (23 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1545-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1545-2017 is the English-translated version of 血液透析用浓缩物与血液透析设备连接的评价.
YY/T 1545-2017 is the Chinese pharmaceutical industry standard that sets the requirements for evaluating the connection between the containers of haemodialysis concentrates - liquid concentrate and dry powder - and the dialysis machine.
It covers the connectors and their compatibility, the tightness and the strength of the connection, and the protection against wrong connection, and it applies to the means of connection supplied by the maker or seller of the concentrate and by the user. Issued on 2 May 2017, it has applied since 1 April 2018.
Found what you need?
Document preview — YY/T 1545-2017
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
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 General
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the dialysis concentrate, dialysis powder and other hemodialysis concentrates containers and hemodialysis equipment connected to the evaluation requirements.
NOTE The means of connection provided by the manufacturer, seller or user of hemodialysis concentrates and hemodialysis equipment shall meet the requirements of this standard.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 13074 blood purification terms Pharmacopoeia of the People's Republic of China (2010 edition 2)
3 Terms and definitions GB/T 13074 defined
terms and definitions apply to this document.
4 General rules
4.1 Purpose
This standard was developed to reduce the risk of hemodialysis concentrates being contaminated during hemodialysis and slowing the dialysis concentrate's Volatile.
4.2 Principles
At this stage, hemodialysis concentrate and hemodialysis equipment there are a variety of connections, the standard hemodialysis concentrate in the course of treatment In the changes and possible secondary pollution evaluation.
4.3 Evaluation Indicators
4.3.1 Visible foreign body
Hemodialysis equipment and dialysis concentrate connected, placed 12h, concentrate should be no visible foreign body.
4.3.2 Particles
Hemodialysis equipment and dialysate concentrate connected, placed 12h, dialysate concentrate diluted into dialysate after the insoluble particulate condition.
Microparticles >=10 µm should not be larger than 25/mL, and particles >= 25 µm should not be larger than 3/mL.
4.3.3 Conductivity
Hemodialysis equipment and dialysis concentrate connected, placed 12h, dialysis concentrate diluted to dialysis fluid conductivity should be at
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
How to Download YY/T 1545-2017
- 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 13074-1991 — Terms of blood purification--Hemodialysis and hemofiltration
GB/T 13074-2009 — Terms of blood purification
GB/T 13074-2024 — Blood purification terminology
Secure payment via Stripe
Payments accepted
YY/T 1545-2017
$105.00