CL-2022-000676 - [2025] EWHC 2486 (Comm)

That means that technically speaking, it is not necessary to establish the answer to this question.

However, for clarity it is neither here nor there that the only EN standard with which the Contract explicitly required compliance was BS EN 13795-1:2019, that this was the only “EN#” checked in Section 6 of the Order Form, and it was the only quality assurance standard referred to in paragraph 3 of Schedule 1. Nor does it matter that Medpro never provided documents demonstrating compliance with EN 556-1, or that it was Mr Graham’s evidence that the Technical Team had advised him directly that the standard with which the gowns were required to conform was EN 13795-1:2019.

Equally there is no need (as DHSC sometimes suggested) to see the reliance on the ISO 11137:1 certificate as evincing an intention to comply with EN-556-1. Medpro is right, and DHSC’s witnesses accepted that that ISO 11137 was different to, and did not constitute compliance with, EN-556-1. ISO 11137 gave a route to a validated process for the relevant SAL. EN-556-1 defines the SAL often used for medical devices.

However, the Contract explicitly (and independently of EN-556-1) required SAL 10^-6. The Contract required a validated process relevant to establishing SAL 10^-6. That is, in essence, what EN-556 required. To the extent that EN-556 required more than these two elements, there might be scope for saying that EN-556 was not required -not least because, as Medpro have repeatedly said, the contractual documentation only referred to EN-13795 as the required EN standard.

When one looks at EN-556, there is, as noted above, essentially nothing else of relevance. Accordingly, this question could be answered in two ways: no, EN-556 is not required (separately or distinctly); alternatively the main planks of EN-556 are indeed required via the prior issue. And, specifically, and contrary to Medpro’s submission in closing on the true construction of the Contract Medpro was required to comply with paragraph 4.1 and 4.2 of EN-556-1:

“4.1

For a terminally-sterilized medical device to be designated “STERILE”, the theoretical probability of there being a viable micro-organism present on/in the device shall be equal to or less than 1 : 10 -6

4.2

Compliance shall be shown by the manufacturer or supplier through provision of documentation and records which demonstrate that the devices have been subjected to a validated sterilization process fulfilling 4.1.”