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AAMI 13958:2014
Concentrates for haemodialysis and related therapiesMore info
Specifies minimum requirements for concentrates used for haemodialysis and related therapies. Addressed to the manufacturer of concentrates. Includes spikes. Also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Includes 48 hour TSA method for tests for compliance with microbiological requirements.
| Author | AAMI |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2014-08-15 |
| ICS | 11.040.20 : Transfusion, infusion and injection equipment |
| Replace | ANSI/AAMI/ISO 13958 (2009) |
| Cross references | ISO 13958 (2014-04), MOD |
| Year | 2014 |
| Document history | ANSI/AAMI 13958 (2014) |
| Country | USA |
| Keyword | ANSI 13958;13958;ANSI/AAMI 13958-2014 |