Writing a CSSD consumables tender: a specification checklist
What to specify for reels, Tyvek, crepe wrap, indicators, Bowie-Dick packs, ECG electrodes and paper in a hospital tender, and which documents to request.
In short: a good CSSD tender specifies each item by standard, class, dimensions, compatibility and shelf life — not by brand — and asks for the documents that prove it. Clear specifications get comparable bids and fewer disputes at delivery.
General requirements for every line
- DRAP licence of the bidder and DRAP enlistment or registration of the product.
- Manufacturer’s ISO 13485 certificate and CE (EU MDR) or equivalent conformity evidence.
- Minimum remaining shelf life at delivery (for example, at least two-thirds of total shelf life).
- Batch number and expiry on every unit and on the delivery note; certificate of conformity per consignment.
- Samples for evaluation before award, for items where performance matters at the point of use.
Line-by-line specification points
| Item | Specify |
|---|---|
| Paper-film sterilization reels | Width × length (e.g. 100 mm × 200 m); medical paper grammage; PET/PP film; printed indicators for steam and EO; conformity to EN 868-5 and ISO 11607-1. |
| Tyvek®-film reels | Width × length; Tyvek® grade; declared compatibility with H₂O₂ plasma (and EO if needed); printed plasma indicator; EN 868-5 and ISO 11607-1. |
| Crepe wrapping paper | Sheet size; colour; declared processes (steam, EO); EN 868-2. |
| Indicator tape | Process (steam, EO or plasma); width × length; Class 1 to ISO 11140-1; colour change stated. |
| In-pack indicator strips | Process; class (4, 5 or 6) to ISO 11140-1; for Class 6, the exact cycle (e.g. 134 °C / 3.5 min); quantity per box. |
| Bowie-Dick test packs | Test cycle (134 °C / 3.5 min); ISO 11140-4; single-use; pack count. |
| ECG electrodes | Ag/AgCl sensor; gel type; backing; diameter; adult or paediatric; ANSI/AAMI EC12. |
| ECG and CTG paper | Machine make and model, or OEM part number; width; Z-fold or roll; sheets per pack or length per roll. |
Writing specifications that stay neutral
Describe the performance and the standard, then add “or equivalent” where a brand or OEM part number is used for identification only, such as for ECG paper made for a particular recorder. Avoid dimensions or features that only one maker can meet unless there is a clinical reason.
Evaluation and delivery
- Score technical compliance first, then price, so non-compliant low bids do not win by default.
- Ask for a delivery schedule and the depot that will supply, so stock-outs are less likely across the contract period.
- Agree how complaints and non-conforming deliveries will be handled before award.
ProDr supplies tender documentation packs for SteriCraft®, PolarCraft™ and EchoGrand™ lines — see tender support for buyers.