Technical Documents
Everything below is what we hold on file for our biological indicators and the instruments we supply with them. Where a document can be published in full, we publish it. Where publishing it in full would disclose things that are not yours to see — other manufacturers’ model ranges, for instance — we send it on request instead, and we tell you that is what we are doing.
Available to download
No form, no email address, no gate.
Available on request
Two documents are sent individually rather than published as direct links:
- The full third-party laboratory report (XDX522601161208BST, 12 pages) — the complete clause-by-clause verification.
- D-value test reports — SCBI-24H-001 (24-hour series) and SCBI-RAPID-001 (20-minute, 1-hour and 3-hour series).
- Certificates of Analysis — issued per production batch, with that batch’s measured population and D-value.
- Technical Data Sheets for the Auto Reader and the incubator — we are completing a model cross-check on these two instruments before publishing their sheets. Ask and we will send the sheet for the exact unit you are buying, rather than a sheet for a unit that may not be the one in the box.
The complete 12-page laboratory report is available on request. The laboratory report covers a wider range of models than the four we sell, including sterilization processes we do not supply. We remove those model references before sending it, because listing them would mislead you about what you are buying. Nothing about the test method, the standards or the result is removed. If you need the unredacted report for an audit, say so in the form and we will discuss it.
Find the documents for your product
Each product page carries the same document set for that specific SKU, so you always see what applies to the item you are buying.
Who we are
CliniEco Medical is the brand owner and the Canadian importer and distributor of these products, operating under Health Canada MDEL #35334 (importer and distributor, Class I and Class II). Manufacturing is carried out by Chengdu QAMED Co., Ltd. (No.80 & 82 Jiangling Road, Xindu District, Chengdu, China), holder of ISO 13485 certificate 280012038605752, valid to 7 March 2029; the manufacturer’s name and address also appear on the product label, as Canadian medical device labelling requires.
If a document you need is not listed here, ask. If it does not exist, we will tell you that it does not exist rather than leave the question open.